Djo Surgical: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Djo Surgical” (first 2009, latest 2009), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 39 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 Enovis (DJO), 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 |
|---|---|---|---|
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | 1 | 0 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Djo Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092873 | REVERSE SHOULDER PROSTHESIS | PHX | 2009-10-27 | 39 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N980003 | PMA | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM | 2003-11-26 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-02-07.
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 Djo Surgical?
FDA lists 1 510(k) clearance under the applicant name “Djo Surgical” (first 2009, latest 2009), plus 1 PMA decision, across 2 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 Djo Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Djo Surgical is 39 days.
Which FDA product codes appear under Djo Surgical?
The most frequent FDA product codes under this applicant name are MRA (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented, 1); PHX (Shoulder Prosthesis, Reverse Configuration, 1).
Next steps
- See all 1 Djo Surgical clearances with predicates and recalls
- Run predicate analysis for product code MRA, Djo Surgical'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.