Orthomedics: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Orthomedics” (first 1980, latest 1983), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | 5 | 5 |
| IPY | Orthosis, Lumbo-Sacral | 3 | 3 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | 3 | 3 |
| IOZ | Splint, Abduction, Congenital Hip Dislocation | 1 | 1 |
| IQK | Orthosis, Cervical | 1 | 1 |
| ISS | Prosthesis, Thigh Socket, External Component | 1 | 1 |
| ITM | Cage, Knee | 1 | 1 |
Plus 1 more product codes.
Review panels
- Physical Medicine (15)
Most recent Orthomedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | ITM | 1983-09-20 | 36 |
| K832741 | JASON CERVICAL ORTHOSIS | IQF | 1983-09-20 | 36 |
| K832740 | FEMORAL FRACTURE ORTHOSIS | — | 1983-09-20 | 36 |
| K811456 | ORTHO-FRAC KIT | IQI | 1981-06-12 | 21 |
| K811298 | EXECUTIVE COLLAR | IQK | 1981-05-27 | 16 |
| K811297 | CERVICAL SUPPORT | IQF | 1981-05-27 | 16 |
| K810557 | HIP ABDUCTION SPLINT | IOZ | 1981-03-13 | 11 |
| K810556 | SPINAL EXTENSION BRACE | IPY | 1981-03-13 | 11 |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | IQF | 1981-03-13 | 11 |
| K810554 | LUMBAR FLEXION BRACE | IPY | 1981-03-13 | 11 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthomedics.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Orthomedics (a text match, not an official crosswalk):
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system (via ISS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthomedics?
FDA lists 16 510(k) clearances under the applicant name “Orthomedics” (first 1980, latest 1983), across 8 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 Orthomedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthomedics is 24 days.
Which FDA product codes appear under Orthomedics?
The most frequent FDA product codes under this applicant name are IQI (Orthosis, Limb Brace, 5); IPY (Orthosis, Lumbo-Sacral, 3); IQF (Orthosis, Cervical-Thoracic, Rigid, 3).
Next steps
- See all 16 Orthomedics clearances with predicates and recalls
- Run predicate analysis for product code IQI, Orthomedics'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.