Centerpulse Orthopedics, Inc.
Austin, TX, US
Centerpulse Orthopedics, Inc. appears in FDA device records in Austin, TX. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Centerpulse Orthopedics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Zimmer Austin, Inc.510(k), recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Centerpulse Orthopedics, Inc. between 2003 and 2005. The busiest year on record is 2003, with 6. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 6 |
| 2004 | 5 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043356 | WAGNER SL REVISION STEM LATERAL | LZO | Substantially Equivalent | |
| K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED | KWA | Substantially Equivalent | |
| K042249 | CLS SPOTORNO STEM | LZO | Substantially Equivalent | |
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED | KWA | Substantially Equivalent | |
| K040947 | DURASUL BIPOLAR | KWY | Substantially Equivalent | |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | HRY | Substantially Equivalent | |
| K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM | LZO | Substantially Equivalent | |
| K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP | LZO | Substantially Equivalent | |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | KWZ | Substantially Equivalent | |
| K032380 | WAGNER CONE PROSTHESIS | LZO | Substantially Equivalent | |
| K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE | JWH | Substantially Equivalent | |
| K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | LZO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0539-05 | MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717 | Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications. | Terminated | ||
| Z-0809-04 | RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas | Compalints of acetabular shell disassociating with the bone. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain