510(k) Report

FDA applicant

Orthopedic Systems, Inc.

Hayward, CA95 decisions1977–19961 recall

FDA records 95 decisions for Orthopedic Systems, Inc. (Hayward, CA) from 1977 to 1996: 95 510(k) clearances. Most are in product codes HST (Apparatus, Traction, Non-Powered) and FWZ (Operating Room Accessories Table Tray). 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 Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthopedic Systems, Inc. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • HSTApparatus, Traction, Non-Powered8decisions
  • FWZOperating Room Accessories Table Tray8decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7decisions
  • HRXArthroscope6decisions
  • HWCScrew, Fixation, Bone4decisions
  • KQXGoniometer, Ac-Powered3decisions

Also: LWJ (3), HXY (2), JEA (2), IKK (2), JDG (2), IQM (2).

Who builds on its devices?

Later devices cite its devices 3 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.

  • K822885Halo Traction Cervical ImmobilizationOrthopedic Systems, Inc. · 19821cites it
  • K832494ScoliometerOrthopedic Systems, Inc. · 19831cites it
  • K881288Corin Modular Moore StemOrthopedic Systems, Inc. · 19881cites it

What has FDA decided for it lately?

  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996
  • K920256Spine Motion Analyzer with EmgOrthopedic Systems, Inc. · 1992
  • K910736Jackson Multipurpose Operating TableOrthopedic Systems, Inc. · 19911 recall
  • K910031Park City Shoulder PositionerOrthopedic Systems, Inc. · 1991
  • K903938C Fit CupOrthopedic Systems, Inc. · 1991
  • K892503Nuffield Total KneeOrthopedic Systems, Inc. · 1990
  • K896678Silicone PlugOrthopedic Systems, Inc. · 1990
  • K894283Comprehensive Spine Motion AnalyzerOrthopedic Systems, Inc. · 1990

All 95 as Orthopedic Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K910736Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to…Jul 29, 2011