510(k) Report

FDA applicant

Advanced Bio-Surfaces, Inc.

Minneapolis, MN2 decisions2006–20080 recalls

FDA records 2 decisions for Advanced Bio-Surfaces, Inc. (Minneapolis, MN) from 2006 to 2008: 2 510(k) clearances. All are in product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing…). Its devices cite 5 predicates, 1 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 Advanced Bio-Surfaces, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Bio-Surfaces, 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?

  • HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 20061cites it

What has FDA decided for it lately?

  • K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc. · 2008
  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 2006

All 2 as Advanced Bio-Surfaces, Inc. →