Sulzer Orthopedics, Inc.: FDA clearances and approvals
Sulzer Orthopedics, Inc. has 45 FDA 510(k) clearances (first 1997, latest 2002), across 13 product codes in 1 review panel. Median 510(k) review time: 85 days.
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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 10 | 10 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 9 | 9 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 9 | 9 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 5 | 5 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 3 | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| HSH | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) | 1 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (45)
Most recent Sulzer Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022985 | ASCENDENT ACETABULAR SYSTEM | LZO | 2002-12-05 | 87 |
| K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE | JWH | 2002-08-09 | 87 |
| K020713 | MS-30 LATERAL FEMORAL STEM | LZO | 2002-05-14 | 70 |
| K013935 | ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS | LZO | 2001-12-13 | 15 |
| K013031 | MOST OPTIONS SYSTEM | KRO | 2001-12-07 | 88 |
| K012739 | CONVERGE ACETABULAR SYSTEM | LPH | 2001-11-14 | 90 |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | JDI | 2001-10-18 | 44 |
| K011954 | SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE | HSX | 2001-09-19 | 89 |
| K010839 | CLS VARUS STEM/CLS 135 STEM | LZO | 2001-04-18 | 28 |
| K003758 | ALLOFIT ACETABULAR SYSTEM | KWA | 2001-03-07 | 91 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sulzer Orthopedics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sulzer Orthopedics, Inc. have?
Sulzer Orthopedics, Inc. has 45 FDA 510(k) clearances (first 1997, latest 2002), across 13 product codes in 1 review panel.
How long does FDA take to clear Sulzer Orthopedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sulzer Orthopedics, Inc.'s cleared 510(k)s is 85 days.
What devices does Sulzer Orthopedics, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 10); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 9); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 9).
Has Sulzer Orthopedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sulzer Orthopedics, Inc. Related entities may recall under other names.
Next steps
- See all 45 Sulzer Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Sulzer Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.