Centerpulse Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Centerpulse Orthopedics, Inc.” (first 2003, latest 2004), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Centerpulse Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED | KWA | 2004-10-18 | 304 |
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED | KWA | 2004-09-15 | 301 |
| K040947 | DURASUL BIPOLAR | KWY | 2004-08-27 | 137 |
| K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM | HRY | 2004-03-05 | 88 |
| K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM | LZO | 2003-12-17 | 26 |
| K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP | LZO | 2003-10-24 | 86 |
| K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER | KWZ | 2003-10-03 | 193 |
| K032380 | WAGNER CONE PROSTHESIS | LZO | 2003-09-22 | 52 |
| K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE | JWH | 2003-07-14 | 90 |
| K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | LZO | 2003-03-06 | 30 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-09-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Centerpulse Spine-Tech, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Centerpulse Orthopedics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Centerpulse Orthopedics, Inc.” (first 2003, latest 2004), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Centerpulse Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Centerpulse Orthopedics, Inc. is 89 days.
Which FDA product codes appear under Centerpulse Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 4); KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 2); HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, 1).
Next steps
- See all 10 Centerpulse Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZO, Centerpulse Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.