Identity
- Trade Name
- COPAL® knee moulds FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Device Name
- COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised. FDA UDI
- Model / Reference
- L FDA UDI
- Description
- COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised. FDA UDI
Identifiers
- Catalog Number
- 5159870 FDA UDI
- Primary DI / UDI-DI
- 04260102139299 FDA UDI
- 510(k) Number
- K222570 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement spacer mould
COPAL® knee moulds by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement spacer mould.
- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
- STAGEONE — Biomet Orthopedics, Inc. · Class II
- SURESPACE — ORTHO DEVELOPMENT CORP. · Class II
- StageOne Select — Biomet Orthopedics, Inc. · Class II
- CeMend 10-48 mold insert press — G21 SRL · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K222570 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (1)
- FDA UDI ccc3db1b-f4ab-4103-919f-f955074a5f65 35 fields · synced May 30, 2026