Orthomet, Inc.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under the applicant name “Orthomet, Inc.” (first 1986, latest 1995), across 20 product codes in 3 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 19 | 19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 16 | 16 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 4 | 4 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| HMC | Monitor, Eye Movement, Diagnostic | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Plus 10 more product codes.
Review panels
- Orthopedic (56)
- Microbiology (1)
- Ophthalmic (1)
Most recent Orthomet, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT | LPH | 1995-06-07 | 426 |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | JDG | 1995-05-30 | 186 |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | LXH | 1995-04-26 | 260 |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | KXA | 1994-12-28 | 93 |
| K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM | JDI | 1994-11-30 | 652 |
| K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | JWH | 1994-10-18 | 671 |
| K932677 | AXIOM TOTAL KNEE SYSTEM | JWH | 1994-10-14 | 499 |
| K931678 | ORTHOMET LHMC FEMORAL STEM | HMC | 1994-10-14 | 556 |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | LPH | 1994-10-14 | 577 |
| K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | KWY | 1994-01-07 | 431 |
50 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthomet, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthomet, Inc.?
FDA lists 60 510(k) clearances under the applicant name “Orthomet, Inc.” (first 1986, latest 1995), across 20 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthomet, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthomet, Inc. is 92 days.
Which FDA product codes appear under Orthomet, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 19); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 16); KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 4).
Next steps
- See all 60 Orthomet, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Orthomet, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.