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Biomet Persona Partial Knee System - HSA Registration DE0503105

Access comprehensive regulatory information for Biomet Persona Partial Knee System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503105 and owned by Biomet Orthopedics. The device was registered on May 16, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0503105
Biomet Persona Partial Knee System
HSA Registration Number: DE0503105
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Product Description

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications: - Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis; - traumatic arthritis; - previous tibial condyle or plateau fractures with loss of anatomy or function; - varus deformities; and - revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged. The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503105
Registration Date
May 16, 2019
Change Notification Approval Date
September 28, 2022
Retention Due Date
May 15, 2025
Product Owner
Short Name
Biomet Orthopedics
Address
56 East Bell Drive, P.O. Box 587, Warsaw, Indiana, 46581, UNITED STATES
Registrant
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model Information
Model Name(s)
Persona Partial Knee Femoral Peg Drill Persona Partial Knee Articular Surface Provisional, Medial, Size C, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size C, 9mm Persona Partial Knee Articular Surface Provisional, Medial,Size C, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size C, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size D, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size D, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size E, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size E, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size F, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size F, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 8mm Persona Partial Knee Articular Surface Provisional, Medial Size G, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size G, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 8mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size H, 14mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 8mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 9mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 10mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 11mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 12mm Persona Partial Knee Articular Surface Provisional, Medial, Size J, 14mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size C, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size D, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size E, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size F, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size G, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size H, 14 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 8 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 9 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 10 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 11 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 12 mm Persona Partial Knee VE Articular Surface, Left Medial, Size J, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size C, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size D, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size E, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size F, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size G, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size H, 14 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 8 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 9 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 10 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 11 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 12 mm Persona Partial Knee VE Articular Surface, Right Medial, Size J, 14 mm Persona Partial Knee Articular Surface Inserter Tip Persona Partial Knee System Tibia, Left Medial, Size C Persona Partial Knee System Tibia, Right Medial, Size C Persona Partial Knee System Tibia, Left Medial, Size D Persona Partial Knee System Tibia, Right Medial, Size D Persona Partial Knee System Tibia, Left Medial, Size E Persona Partial Knee System Tibia, Right Medial, Size E Persona Partial Knee System Tibia, Left Medial, Size F Persona Partial Knee System Tibia, Right Medial, Size F Persona Partial Knee System Tibia, Left Medial, Size G Persona Partial Knee System Tibia, Right Medial, Size G Persona Partial Knee System Tibia, Left Medial, Size H Persona Partial Knee System Tibia, Right Medial, Size H Persona Partial Knee System Tibia, Left Medial, Size J Persona Partial Knee System Tibia, Right Medial, Size J Persona Partial Knee Tibial Provisional Left Medial, Size C Persona Partial Knee Tibial Provisional Right Medial, Size C Persona Partial Knee Tibial Provisional Left Medial, Size D Persona Partial Knee Tibial Provisional Right Medial, Size D Persona Partial Knee Tibial Provisional Left Medial, Size E Persona Partial Knee Tibial Provisional Right Medial, Size E Persona Partial Knee Tibial Provisional Left Medial, Size F Persona Partial Knee Tibial Provisional Right Medial, Size F Persona Partial Knee Tibial Provisional Left Medial, Size G Persona Partial Knee Tibial Provisional Right Medial, Size G Persona Partial Knee Tibial Provisional Left Medial, Size H Persona Partial Knee Tibial Provisional Right Medial, Size H Persona Partial Knee Tibial Provisional Left Medial, Size J Persona Partial Knee Tibial Provisional Right Medial, Size J Persona Partial Knee Cemented Femoral, Left Medial, Size 1 Persona Partial Knee Cemented Femoral, Right Medial, Size 1 Persona Partial Knee Cemented Femoral, Left Medial, Size 2 Persona Partial Knee Cemented Femoral, Right Medial, Size 2 Persona Partial Knee Cemented Femoral, Left Medial, Size 3 Persona Partial Knee Cemented Femoral, Right Medial, Size 3 Persona Partial Knee Cemented Femoral, Left Medial, Size 4 Persona Partial Knee Cemented Femoral, Right Medial, Size 4 Persona Partial Knee Cemented Femoral, Left Medial, Size 5 Persona Partial Knee Cemented Femoral, Right Medial, Size 5 Persona Partial Knee Cemented Femoral, Left Medial, Size 6 Persona Partial Knee Cemented Femoral, Right Medial, Size 6 Persona Partial Knee Cemented Femoral, Left Medial, Size 7 Persona Partial Knee Cemented Femoral, Right Medial, Size 7 Persona Partial Knee Cemented Femoral, Left Medial, Size 8 Persona Partial Knee Cemented Femoral, Right Medial, Size 8 Persona Partial Knee Femoral Provisional Left Medial, Size 1 Persona Partial Knee Femoral Provisional Right Medial, Size 1 Persona Partial Knee Femoral Provisional Left Medial, Size 2 Persona Partial Knee Femoral Provisional Right Medial, Size 2 Persona Partial Knee Femoral Provisional Left Medial, Size 3 Persona Partial Knee Femoral Provisional Right Medial, Size 3 Persona Partial Knee Femoral Provisional Left Medial, Size 4 Persona Partial Knee Femoral Provisional Right Medial, Size 4 Persona Partial Knee Femoral Provisional Left Medial, Size 5 Persona Partial Knee Femoral Provisional Right Medial, Size 5 Persona Partial Knee Femoral Provisional Left Medial, Size 6 Persona Partial Knee Femoral Provisional Right Medial, Size 6 Persona Partial Knee Femoral Provisional Left Medial, Size 7 Persona Partial Knee Femoral Provisional Right Medial, Size 7 Persona Partial Knee Femoral Provisional Left Medial, Size 8 Persona Partial Knee Femoral Provisional Right Medial, Size 8
Model Identifier(s)
42-5099-042-00 42-5181-003-08 42-5181-003-09 42-5181-003-10 42-5181-003-11 42-5181-003-12 42-5181-003-14 42-5181-004-08 42-5181-004-09 42-5181-004-10 42-5181-004-11 42-5181-004-12 42-5181-004-14 42-5181-005-08 42-5181-005-09 42-5181-005-10 42-5181-005-11 42-5181-005-12 42-5181-005-14 42-5181-006-08 42-5181-006-09 42-5181-006-10 42-5181-006-11 42-5181-006-12 42-5181-006-14 42-5181-007-08 42-5181-007-09 42-5181-007-10 42-5181-007-11 42-5181-007-12 42-5181-007-14 42-5181-008-08 42-5181-008-09 42-5181-008-10 42-5181-008-11 42-5181-008-12 42-5181-008-14 42-5181-009-08 42-5181-009-09 42-5181-009-10 42-5181-009-11 42-5181-009-12 42-5181-009-14 42-5182-003-08 42-5182-003-09 42-5182-003-10 42-5182-003-11 42-5182-003-12 42-5182-003-14 42-5182-004-08 42-5182-004-09 42-5182-004-10 42-5182-004-11 42-5182-004-12 42-5182-004-14 42-5182-005-08 42-5182-005-09 42-5182-005-10 42-5182-005-11 42-5182-005-12 42-5182-005-14 42-5182-006-08 42-5182-006-09 42-5182-006-10 42-5182-006-11 42-5182-006-12 42-5182-006-14 42-5182-007-08 42-5182-007-09 42-5182-007-10 42-5182-007-11 42-5182-007-12 42-5182-007-14 42-5182-008-08 42-5182-008-09 42-5182-008-10 42-5182-008-11 42-5182-008-12 42-5182-008-14 42-5182-009-08 42-5182-009-09 42-5182-009-10 42-5182-009-11 42-5182-009-12 42-5182-009-14 42-5282-003-08 42-5282-003-09 42-5282-003-10 42-5282-003-11 42-5282-003-12 42-5282-003-14 42-5282-004-08 42-5282-004-09 42-5282-004-10 42-5282-004-11 42-5282-004-12 42-5282-004-14 42-5282-005-08 42-5282-005-09 42-5282-005-10 42-5282-005-11 42-5282-005-12 42-5282-005-14 42-5282-006-08 42-5282-006-09 42-5282-006-10 42-5282-006-11 42-5282-006-12 42-5282-006-14 42-5282-007-08 42-5282-007-09 42-5282-007-10 42-5282-007-11 42-5282-007-12 42-5282-007-14 42-5282-008-08 42-5282-008-09 42-5282-008-10 42-5282-008-11 42-5282-008-12 42-5282-008-14 42-5282-009-08 42-5282-009-09 42-5282-009-10 42-5282-009-11 42-5282-009-12 42-5282-009-14 42-5299-003-01 42-5380-003-01 42-5380-003-02 42-5380-004-01 42-5380-004-02 42-5380-005-01 42-5380-005-02 42-5380-006-01 42-5380-006-02 42-5380-007-01 42-5380-007-02 42-5380-008-01 42-5380-008-02 42-5380-009-01 42-5380-009-02 42-5381-003-01 42-5381-003-02 42-5381-004-01 42-5381-004-02 42-5381-005-01 42-5381-005-02 42-5381-006-01 42-5381-006-02 42-5381-007-01 42-5381-007-02 42-5381-008-01 42-5381-008-02 42-5381-009-01 42-5381-009-02 42-5580-001-01 42-5580-001-02 42-5580-002-01 42-5580-002-02 42-5580-003-01 42-5580-003-02 42-5580-004-01 42-5580-004-02 42-5580-005-01 42-5580-005-02 42-5580-006-01 42-5580-006-02 42-5580-007-01 42-5580-007-02 42-5580-008-01 42-5580-008-02 42-5581-001-01 42-5581-001-02 42-5581-002-01 42-5581-002-02 42-5581-003-01 42-5581-003-02 42-5581-004-01 42-5581-004-02 42-5581-005-01 42-5581-005-02 42-5581-006-01 42-5581-006-02 42-5581-007-01 42-5581-007-02 42-5581-008-01 42-5581-008-02