Orthopedic Systems, Inc.: FDA filings under this applicant name
FDA lists 95 510(k) clearances under the applicant name “Orthopedic Systems, Inc.” (first 1977, latest 1996), across 45 product codes in 9 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | 8 | 8 |
| HST | Apparatus, Traction, Non-Powered | 8 | 8 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| HRX | Arthroscope | 6 | 6 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| KQX | Goniometer, Ac-Powered | 3 | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 3 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 | 2 |
| HXY | Brace, Drill | 2 | 2 |
| IKK | System, Isokinetic Testing And Evaluation | 2 | 2 |
Plus 35 more product codes.
Review panels
- Orthopedic (36)
- General and Plastic Surgery (19)
- Neurology (13)
- Physical Medicine (11)
- General Hospital (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent Orthopedic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | LXH | 1996-01-22 | 237 |
| K920256 | SPINE MOTION ANALYZER WITH EMG | KQX | 1992-08-10 | 202 |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | JEA | 1991-05-21 | 89 |
| K910031 | PARK CITY SHOULDER POSITIONER | FWZ | 1991-01-24 | 20 |
| K903938 | C FIT CUP | JDI | 1991-01-04 | 130 |
| K892503 | NUFFIELD TOTAL KNEE | JWH | 1990-05-04 | 388 |
| K896678 | SILICONE PLUG | HRX | 1990-01-30 | 64 |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | KQX | 1990-01-19 | 210 |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | JDI | 1989-10-13 | 254 |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | LWJ | 1989-10-13 | 263 |
85 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-02-14.
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.
- Orthopedic Equipment Co., Inc. (45 510(k)s)
- Orthopedic Sciences, Inc. (11 510(k)s)
- Orthopedic Designs, Inc. (4 510(k)s)
- Orthopedic Designs North America, Inc. (4 510(k)s)
- Orthopedic Alliance, LLC (3 510(k)s)
- Orthopedic Source, Inc. (3 510(k)s)
- Orthopedic Development, Inc. (2 510(k)s)
- Orthopedic Technology, Inc. (2 510(k)s)
- Orthopedic Technology Research, Inc. (2 510(k)s)
- Orthopedic Designs, Inc. (Odi) (1 510(k)s)
- Orthopedic Designs North America, Inc. (Odi-Na) (1 510(k)s)
- Orthopedic Driven Imaging, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthopedic Systems, Inc.?
FDA lists 95 510(k) clearances under the applicant name “Orthopedic Systems, Inc.” (first 1977, latest 1996), across 45 product codes in 9 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 Orthopedic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthopedic Systems, Inc. is 28 days.
Which FDA product codes appear under Orthopedic Systems, Inc.?
The most frequent FDA product codes under this applicant name are FWZ (Operating Room Accessories Table Tray, 8); HST (Apparatus, Traction, Non-Powered, 8); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7).
Next steps
- See all 95 Orthopedic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWZ, Orthopedic Systems, 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.