510(k) Report

FDA applicant

Dj Orthopedics, LLC

Vista, CA6 decisions2001–20020 recalls

FDA records 6 decisions for Dj Orthopedics, LLC (Vista, CA) from 2001 to 2002: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Dj Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dj Orthopedics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dj Orthopedics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dj Orthopedics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue2decisions
  • HWCScrew, Fixation, Bone2decisions
  • HRSPlate, Fixation, Bone1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021740Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 20023cite it
  • K010595DJ Orthopedics Interference ScrewDj Orthopedics, LLC · 20012cite it

What has FDA decided for it lately?

  • K021740Total Knee Cemented, Semi-ConstrainedDj Orthopedics, LLC · 2002
  • K011354High Tibial Osteotomy Plating SystemDj Orthopedics, LLC · 2001
  • K010594DJ Orthopedics Post ScrewDj Orthopedics, LLC · 2001
  • K010595DJ Orthopedics Interference ScrewDj Orthopedics, LLC · 2001
  • K002829DJ Orthopedics Femoral AnchorDj Orthopedics, LLC · 2001
  • K003960DJ Orthopedics Tibial AnchorDj Orthopedics, LLC · 2001

All 6 as Dj Orthopedics, LLC →