Dj Orthopedics, LLC: FDA clearances and approvals
Dj Orthopedics, LLC has 6 FDA 510(k) clearances (first 2001, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Dj Orthopedics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021740 | TOTAL KNEE CEMENTED, SEMI-CONSTRAINED | JWH | 2002-09-23 | 118 |
| K011354 | HIGH TIBIAL OSTEOTOMY PLATING SYSTEM | HRS | 2001-07-31 | 89 |
| K010594 | DJ ORTHOPEDICS POST SCREW | HWC | 2001-05-29 | 90 |
| K010595 | DJ ORTHOPEDICS INTERFERENCE SCREW | HWC | 2001-05-08 | 69 |
| K002829 | DJ ORTHOPEDICS FEMORAL ANCHOR | MBI | 2001-03-26 | 196 |
| K003960 | DJ ORTHOPEDICS TIBIAL ANCHOR | MBI | 2001-03-21 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Dj Orthopedics, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dj Orthopedics, LLC have?
Dj Orthopedics, LLC has 6 FDA 510(k) clearances (first 2001, latest 2002), across 4 product codes in 1 review panel.
How long does FDA take to clear Dj Orthopedics, LLC's 510(k)s?
The median time from FDA receipt to decision across Dj Orthopedics, LLC's cleared 510(k)s is 90 days.
What devices does Dj Orthopedics, LLC make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 2); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); HRS (Plate, Fixation, Bone, 1).
Has Dj Orthopedics, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Dj Orthopedics, LLC. Related entities may recall under other names.
Next steps
- See all 6 Dj Orthopedics, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Dj Orthopedics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.