510(k) Report

FDA applicant

Orthopedic Alliance, LLC

Murrieta, CA3 decisions2003–20051 recall

FDA records 3 decisions for Orthopedic Alliance, LLC (Murrieta, CA) from 2003 to 2005: 3 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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 Orthopedic Alliance, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopedic Alliance, LLC since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…1decision

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 20043cite it
  • K031474SC Total Hip SystemOrthopedic Alliance, LLC · 20032cite it

What has FDA decided for it lately?

  • K052237SC Ceramic Ball HeadsOrthopedic Alliance, LLC · 2005
  • K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 20041 recall
  • K031474SC Total Hip SystemOrthopedic Alliance, LLC · 2003

All 3 as Orthopedic Alliance, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033826Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap…Mar 7, 2013Class II