Orthopaedic Innovations, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Orthopaedic Innovations, Inc.” (first 1995, latest 2002), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Orthopaedic Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020145 | ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM | LPH | 2002-04-15 | 89 |
| K983881 | COBRA EXTERNAL FIXATOR | HRS | 1998-12-04 | 32 |
| K962646 | PRIME MODULAR ENDO HEAD | KWL | 1996-09-23 | 77 |
| K960014 | PRACTIFIX EXTERNAL FIXATION SYSTEM | KTT | 1996-03-18 | 76 |
| K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS | JDI | 1996-02-20 | 71 |
| K955751 | PRIME FEMORAL CEMENT PLUG | LZN | 1996-01-26 | 37 |
| K953033 | PRIME CEMENTED SMALL FEMORAL STEM | JDI | 1995-09-13 | 75 |
| K940328 | PRIME CEMENTED HIP SYSTEM | JDI | 1995-04-07 | 438 |
Recalls
openFDA lists no recalls under a recalling firm named Orthopaedic Innovations, 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.
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.
- Orthopaedic Biosystems, Ltd. (14 510(k)s)
- Orthopaedic Implant Company (10 510(k)s)
- Orthopaedic Device Corp. (4 510(k)s)
- Orthopaedic Designs, Inc. (2 510(k)s)
- Orthopaedic Device Research Center (1 510(k)s)
- Orthopaedic Devices , Ltd. (1 510(k)s)
- Orthopaedic Medical Group, Inc. (1 510(k)s)
- Orthopaedic Resources Corp. (1 510(k)s)
- Orthopaedic & Spine Development (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthopaedic Innovations, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Orthopaedic Innovations, Inc.” (first 1995, latest 2002), 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 Orthopaedic Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthopaedic Innovations, Inc. is 76 days.
Which FDA product codes appear under Orthopaedic Innovations, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 3); HRS (Plate, Fixation, Bone, 1); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Next steps
- See all 8 Orthopaedic Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Orthopaedic Innovations, 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.