TaperFit Cemented Hip System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Corin Ltd
Identity
- Trade Name
- TaperFit Stem 50mm Offset – Size 1 - 1-hole variant + 188.550 PMMA Stem Centralizer EUDAMEDTaperFit Cemented Hip System FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- TaperFit Stem for use in total hip arthroplasty and hemiarthroplasty EUDAMEDTaperFit Hip Stem 50mm Offset Large Stem size 1 FDA UDI
- Model / Reference
- 588.5001 EUDAMEDFDA UDITaperFit Standard Stem EUDAMED
- Description
- TaperFit Hip Stem 50mm Offset Large Stem size 1 FDA UDI
Identifiers
- Catalog Number
- 588.5001 FDA UDI
- Primary DI / UDI-DI
- 05055343871096 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055343871096 EUDAMED
- 510(k) Number
- K142761 FDA UDI
- FDA Product Code
- JDG FDA UDIJDI FDA UDI
- EMDN Code
- P090804010101 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT EUDAMED
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3350 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Uncoated hip femur prosthesis, modular
TaperFit Cemented Hip System by Corin Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
- Accolade — Howmedica Osteonics Corp. · Class II
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- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
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- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
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- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
Cleared under the same submission
K142761 also covers:
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
- TaperFit Cemented Hip System — CORIN LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Corin Ltd
Sources (2)
- FDA UDI 6329284b-4f30-4e82-bca9-9a9fb64cfa83 36 fields · synced Oct 8, 2026
- EUDAMED 3f7e02b8-2d40-4bbf-a729-234bf01b06a5 61 fields · synced Oct 8, 2026