Identity
- Trade Name
- PALACOS® FDA UDI
- Generic Name
- Orthopaedic cement, antimicrobial FDA UDI
- Device Name
- PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. PALACOS® MV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV+G has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. FDA UDI
- Model / Reference
- MV+G FDA UDI
- Description
- PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. PALACOS® MV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV+G has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. FDA UDI
Identifiers
- Catalog Number
- 5051207 FDA UDI
- Primary DI / UDI-DI
- 04260102135826 FDA UDI
- FDA Product Code
- LOD FDA UDIMBB FDA UDI
- GMDN Term
- Orthopaedic cement, antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
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, antimicrobial
Palacos® by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement, antimicrobial.
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- Unite Cement — OSTEOREMEDIES, LLC · Class II
- MectaCem-X LV with Gentamicin — Tecres · Class II
- BRAVO MV+G — G21 SRL · Class II
- Simplex — Howmedica Osteonics Corp. · Class II
- Cemex Genta HV — Tecres · Class II
- REFOBACIN® BONE CEMENT R — Biomet, Inc. · Class II
Cleared under the same submission
K202475 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 cb680777-2108-4f3a-9aed-bc6d11a42f01 36 fields · synced May 30, 2026