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Smith & Nephew Visionaire Cutting Guides - HSA Registration DE0506628

Access comprehensive regulatory information for Smith & Nephew Visionaire Cutting Guides in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506628 and owned by Smith & Nephew, Inc.. The device was registered on February 08, 2022.

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 B
DE0506628
Smith & Nephew Visionaire Cutting Guides
HSA Registration Number: DE0506628
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Product Description

Smith & Nephew VISIONAIRE Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee replacement components intra- operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of implants are identifiable on patient imagine scans. The VISIONAIRE Cutting Guides are intended for use with the following existing Smith & Nephew knee systems and their cleared indications for use: GENESIS II, LEGION, and JOURNEY II Knee Systems. The VISIONAIRE UK Cutting Guides are intended for use with the following existing Smith & Nephew knee systems and their cleared indications for use: JOURNEY II Unicompartmental Knee (JOURNEY II UK) System.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506628
Registration Date
February 08, 2022
Change Notification Approval Date
December 19, 2024
Retention Due Date
February 07, 2026
Product Owner
Short Name
Smith & Nephew, Inc
Address
1450 Brooks Road, Memphis, Tennessee, 38116, UNITED STATES
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
VISIONAIRE PMCB RT KIT GII SZ F5/T3 (V0100010 - Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in; V0100011 - Length:1.5in Breath:2.1-3.5in Thickness:2.1-2.7in) VISIONAIRE TIBIA PMCB SZ 3 RIGHT / LEFT – GII (Length:1.5in Breath:2.1-3.5in Thickness:2.1-2.7in) VISIONAIRE PMCB LT KIT GII SZ F6/T6 (V0100010 - Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in; V0100011 - Length:1.5in Breath:2.1-3.5in Thickness:2.1-2.7in) VISIONAIRE PMCB RT KIT GII SZ F5/T3 (V0100010 - Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in; V0100011 - Length:1.5in Breath:2.1-3.5in Thickness:2.1-2.7in) Visionaire Femur PMCB – LGNP Primary (Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in) Visionaire Tibia PMCB – LGNP Primary (Length: 1.5in Breath: 2.1-3.5in Thickness: 2.1-2.7in) Visionaire PMCB Kit – LGNP Left (V0100020 - Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in; V0100021 - Length: 1.5in Breath: 2.1-3.5in Thickness: 2.1-2.7in) Visionaire PMCB Kit – LGNP Right (V0100020 - Length: 2.1-2.5in Breath: 2.8-3.4in Thickness:2.4-3.3in; V0100021 - Length: 1.5in Breath: 2.1-3.5in Thickness: 2.1-2.7in) Visionaire Femur PMCB – JBCS (Length: 2.1-2.6in Breadth 2.8-3.4in Thickness 2.3in-3.5in) Visionaire Tibia PMCB – JBCS (Length: 1.5in Breadth: 2.1-3.5in Thickness: 2.1-2.7in) Visionaire PMCB Kit – JBCS Left (V0100030 - Length: 2.1-2.6in Breadth 2.8-3.4in Thickness 2.3in-3.5in; V0100031 - Length: 1.5in Breadth: 2.1-3.5in Thickness: 2.1-2.7in) Visionaire PMCB Kit – JBCS Right (V0100030 - Length: 2.1-2.6in Breadth 2.8-3.4in Thickness 2.3in-3.5in; V0100031 - Length: 1.5in Breadth: 2.1-3.5in Thickness: 2.1-2.7in) VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR GENESIS II (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS II (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) VISIONAIRE ADAPTIVE GUIDE KIT GENESIS II (Consists of V0100104: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0100105: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cutting Guide - W VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR LEGION PRIMARY (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA LEGION PRIMARY (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY(Consists of V0100107: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0100108: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cutting Guide VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR JOURNEY II (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIAL JOURNEY II (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II(Consists of V0100110: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0100111: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cutting Guide - Wi VISIONAIRE UK MEDIAL GUIDE KIT (For Femoral - Specified dimension of Size 1 to 9 with the range from 0.049 - 2.75 inches) (For Tibial - Specified dimension of Size 1 to 9 with the range from 0.049 - 8.0 inches) NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR GENESIS II (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA GENESIS II (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT GENESIS II(Consists of V0200104: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0200105: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cutting NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR LEGION PRIMARY (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIA LEGION PRIMARY (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY(Consists of V0200107: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0200108: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cut NONSTERILE VISIONAIRE ADAPTIVE GUIDE DISTAL FEMUR JOURNEY II (D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE PROXIMAL TIBIAL JOURNEY II (MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) (TAA Cutting Guide - Width1: 71.96-92.08mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm) NONSTERILE VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II(Consists of V0200110: D1: 54.99-85.04mm ; D2: 66.37-96.55mm; D3: 54.64-72.11mm and V0200111: MIS Cutting Guide - Width1: 64.36-90.52mm ; Width2: 48.21-72.21mm ; Height: 40.64-63.12mm and TAA Cutting NONSTERILE VISIONAIRE UK MEDIAL GUIDE KIT (For Femoral - Specified dimension of Size 1 to 9 with the range from 0.049 - 2.75 inches) (For Tibial - Specified dimension of Size 1 to 9 with the range from 0.049 - 8.0 inches)
Model Identifier(s)
V0100010 (length, breath, thickness) V0100011 (breath, thickness) V0100012 (length, breath, thickness) V0100013 (length, breath, thickness) V0100020 (length, breath, thickness) V0100021 (breath, thickness) V0100022 (length, breath, thickness) V0100023 (length, breath, thickness) V0100030 (length, breath, thickness) V0100031 (breath, thickness) V0100032 (length, breath, thickness) V0100033 (length, breath, thickness) V0100104 (length, breath, thickness) V0100105 (length, breath, thickness) V0100106 (length, breath, thickness) V0100107 (length, breath, thickness) V0100108 (length, breath, thickness) V0100109 (length, breath, thickness) V0100110 (length, breath, thickness) V0100111 (length, breath, thickness) V0100112 (length, breath, thickness) V0100128 V0200104 (length, breath, thickness) V0200105 (length, breath, thickness) V0200106 (length, breath, thickness) V0200107 (length, breath, thickness) V0200108 (length, breath, thickness) V0200109 (length, breath, thickness) V0200110 (length, breath, thickness) V0200111 (length, breath, thickness) V0200112 (length, breath, thickness) V0200128