Intermedics Orthopedics: FDA filings under this applicant name
FDA lists 108 510(k) clearances under the applicant name “Intermedics Orthopedics” (first 1982, latest 1997), across 29 product codes in 3 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 21 | 21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 19 | 19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 17 | 17 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 5 | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 5 | 5 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 | 4 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 3 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 | 3 |
Plus 19 more product codes.
Review panels
- Orthopedic (104)
- General and Plastic Surgery (2)
- General Hospital (1)
Most recent Intermedics Orthopedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | LPH | 1997-07-03 | 160 |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | JWH | 1997-04-30 | 79 |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | LZO | 1997-04-08 | 82 |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | KWT | 1997-02-27 | 14 |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | LZO | 1997-01-27 | 87 |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | JDI | 1997-01-16 | 77 |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | KRR | 1996-10-28 | 144 |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | LPH | 1996-10-15 | 56 |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | LWJ | 1996-10-01 | 57 |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | KWT | 1996-09-03 | 78 |
98 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intermedics Orthopedics.
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.
- Intermedics, Inc. (211 510(k)s)
- Intermedics Intraocular, Inc. (4 510(k)s)
- Intermedics/Infusaid, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intermedics Orthopedics?
FDA lists 108 510(k) clearances under the applicant name “Intermedics Orthopedics” (first 1982, latest 1997), across 29 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 Intermedics Orthopedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intermedics Orthopedics is 90 days.
Which FDA product codes appear under Intermedics Orthopedics?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 21); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 19); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 17).
Next steps
- See all 108 Intermedics Orthopedics clearances with predicates and recalls
- Run predicate analysis for product code JDI, Intermedics Orthopedics'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.