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Biomet Arcos Femoral Revision System - HSA Registration DE0506926

Access comprehensive regulatory information for Biomet Arcos Femoral Revision 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 DE0506926 and owned by Biomet Orthopedics. The device was registered on June 02, 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 C
DE0506926
Biomet Arcos Femoral Revision System
HSA Registration Number: DE0506926
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Product Description

The device is indicated for 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Arcos Modular Femoral Revision System hip components are single-use implants, intended for uncemented use only.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506926
Registration Date
June 02, 2022
Retention Due Date
June 01, 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)
Arcos Modular Revision Hip System: STS Distal Stem - 12mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 13mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 14mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 15mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 16mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 17mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 18mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 19mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 20mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 21mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 22mm x 150mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 12mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 13mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 14mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 15mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 16mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 17mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 18mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 19mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 20mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 21mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: STS Distal Stem - 22mm x 190mm - with Locking Screw - Interlok / Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size A, 50mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size A, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size B, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size C, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size D, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size A, 50mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size A, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size B, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size C, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size D, 60mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size A, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size B, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size C, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size D, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size A, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size B, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size C, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size D, 70mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size A, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size B, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size C, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: Standard Cone Prox Body - Size D, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size A, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size B, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size C, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip System: High Offset Cone Prox Body - Size D, 80mm - Type I Taper - Porous Plasma/ Uncemented Arcos Modular Revision Hip system Trochanteric Claw Large 100mm Arcos Modular Revision Hip system Trochanteric Claw Small 100mm Arcos Modular Revision Hip system Trochanteric Button 25mm Arcos Modular Revision Hip system Trochanteric Bolt 24mm Arcos Modular Revision Hip system Trochanteric Bolt 26mm Arcos Modular Revision Hip system Trochanteric Bolt 28mm Arcos Modular Revision Hip system Trochanteric Bolt 30mm Arcos Modular Revision Hip system Trochanteric Bolt 32mm Arcos Modular Revision Hip system Trochanteric Bolt 34mm Arcos Modular Revision Hip system Trochanteric Bolt 36mm Arcos Modular Revision Hip system Trochanteric Bolt 38mm Arcos Modular Revision Hip system Trochanteric Bolt 40mm Arcos Modular Revision Hip system Trochanteric Bolt 42mm Arcos Modular Revision Hip system Trochanteric Bolt 44mm Arcos Modular Revision Hip system Trochanteric Bolt 46mm Arcos Modular Revision Hip system Trochanteric Bolt 48mm Arcos Modular Revision Hip system Trochanteric Bolt 50mm Arcos Modular Revision Hip system Trochanteric Bolt 52mm Arcos Modular Revision Hip system Trochanteric Bolt 54mm Arcos Modular Revision system STS Distal Stem Trial 12mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 13mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 14mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 15mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 16mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 17mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 18mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 19mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 20mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 21mm x 150mm Arcos Modular Revision system STS Distal Stem Trial 22mm x 150mm Arcos Modular Revision system STS Distal Reamer 12mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 13mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 14mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 15mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 16mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 17mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 18mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 19mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 20mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 21mm x 150/250mm Arcos Modular Revision system STS Distal Reamer 22mm x 150/250mm Arcos Modular Revision system STS Distal Stem Trial 12mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 13mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 14mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 15mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 16mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 17mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 18mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 19mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 20mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 21mm x 190mm Arcos Modular Revision system STS Distal Stem Trial 22mm x 190mm Arcos Modular Revision system STS Reamer 12mm x 190mm Arcos Modular Revision system STS Reamer 13mm x 190mm Arcos Modular Revision system STS Reamer 14mm x 190mm Arcos Modular Revision system STS Reamer 15mm x 190mm Arcos Modular Revision system STS Reamer 16mm x 190mm Arcos Modular Revision system STS Reamer 17mm x 190mm Arcos Modular Revision system STS Reamer 18mm x 190mm Arcos Modular Revision system STS Reamer 19mm x 190mm Arcos Modular Revision system STS Reamer 20mm x 190mm Arcos Modular Revision system STS Reamer 21mm x 190mm Arcos Modular Revision system STS Reamer 22mm x 190mm Arcos Modular Revision system Calcar Body Trial Size A 50mm +0 Standard Offset Arcos Modular Revision system Calcar Body Trial Size A 50mm +0 High Offset Arcos Modular Revision system Cone Body Trial Size A 50mm +0 Standard Offset Arcos Modular Revision system Cone Body Trial Size A 60mm Standard Offset Arcos Modular Revision system Cone Body Trial Size B 60mm Standard Offset Arcos Modular Revision system Cone Body Trial Size C 60mm Standard Offset Arcos Modular Revision system Cone Body Trial Size D 60mm Standard Offset Arcos Modular Revision system Cone Body Trial Size A 50mm High Offset Arcos Modular Revision system Cone Body Trial Size A 60mm High Offset Arcos Modular Revision system Cone Body Trial Size B 60mm High Offset Arcos Modular Revision system Cone Body Trial Size C 60mm High Offset Arcos Modular Revision system Cone Body Trial Size D 60mm High Offset Arcos Modular Revision system Cone Body Trial Size A 70mm Standard Offset Arcos Modular Revision system Cone Body Trial Size B 70mm Standard Offset Arcos Modular Revision system Cone Body Trial Size C 70mm Standard Offset Arcos Modular Revision system Cone Body Trial Size D 70mm Standard Offset Arcos Modular Revision system Cone Body Trial Size A 70mm High Offset Arcos Modular Revision system Cone Body Trial Size B 70mm High Offset Arcos Modular Revision system Cone Body Trial Size C 70mm High Offset Arcos Modular Revision system Cone Body Trial Size D 70mm High Offset Arcos Modular Revision system Cone Body Trial Size A 80mm Standard Offset Arcos Modular Revision system Cone Body Trial Size B 80mm Standard Offset Arcos Modular Revision system Cone Body Trial Size C 80mm Standard Offset Arcos Modular Revision system Cone Body Trial Size D 80mm Standard Offset Arcos Modular Revision system Cone Body Trial Size A 80mm High Offset Arcos Modular Revision system Cone Body Trial Size B 80mm High Offset Arcos Modular Revision system Cone Body Trial Size C 80mm High Offset Arcos Modular Revision system Cone Body Trial Size D 80mm High Offset Arcos Modular Revision system Proximal Body Reamer Size A Arcos Modular Revision system Proximal Body Reamer Size B Arcos Modular Revision system Proximal Body Reamer Size C Arcos Modular Revision system Proximal Body Reamer Size D Arcos Modular Revision system Troch Bolt Hole Drill Size A Arcos Modular Revision system Troch Bolt Hole Drill Size B Arcos Modular Revision system Troch Bolt Hole Drill Size C Arcos Modular Revision system Troch Bolt Hole Drill Size D Arcos Modular Revision system Troch Bolt Hole Drill Size E Arcos Modular Revision system Troch Claw Trial 100mm Large Arcos Modular Revision system Troch Claw Trial 100mm Small
Model Identifier(s)
11-300812 11-300813 11-300814 11-300815 11-300816 11-300817 11-300818 11-300819 11-300820 11-300821 11-300822 11-300912 11-300913 11-300914 11-300915 11-300916 11-300917 11-300918 11-300919 11-300920 11-300921 11-300922 11-301300 11-301301 11-301302 11-301303 11-301304 11-301310 11-301311 11-301312 11-301313 11-301314 11-301321 11-301322 11-301323 11-301324 11-301331 11-301332 11-301333 11-301334 11-301341 11-301342 11-301343 11-301344 11-301351 11-301352 11-301353 11-301354 11-302101 11-302102 11-302109 11-302124 11-302126 11-302128 11-302130 11-302132 11-302134 11-302136 11-302138 11-302140 11-302142 11-302144 11-302146 11-302148 11-302150 11-302152 11-302154 31-300812 31-300813 31-300814 31-300815 31-300816 31-300817 31-300818 31-300819 31-300820 31-300821 31-300822 31-300862 31-300863 31-300864 31-300865 31-300866 31-300867 31-300868 31-300869 31-300870 31-300871 31-300872 31-300912 31-300913 31-300914 31-300915 31-300916 31-300917 31-300918 31-300919 31-300920 31-300921 31-300922 31-300962 31-300963 31-300964 31-300965 31-300966 31-300967 31-300968 31-300969 31-300970 31-300971 31-300972 31-301200 31-301210 31-301300 31-301301 31-301302 31-301303 31-301304 31-301310 31-301311 31-301312 31-301313 31-301314 31-301321 31-301322 31-301323 31-301324 31-301331 31-301332 31-301333 31-301334 31-301341 31-301342 31-301343 31-301344 31-301351 31-301352 31-301353 31-301354 31-301361 31-301362 31-301363 31-301364 31-301881 31-301882 31-301883 31-301884 31-301885 31-302101 31-302102