510(k) Report

FDA applicant

A.M. Surgical, Inc.

Smithtown, NY6 decisions1998–20190 recalls

FDA records 6 decisions for A.M. Surgical, Inc. (Smithtown, NY) from 1998 to 2019: 6 510(k) clearances. Most are in product codes EMF (Knife, Surgical) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 4 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 A.M. Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2008: 12018: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — A.M. Surgical, 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?

  • EMFKnife, Surgical2decisions
  • HWCScrew, Fixation, Bone1decision
  • LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite1decision
  • HRXArthroscope1decision
  • HTYPin, Fixation, Smooth1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 106 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K080133Mountable Endoscopic BladeA.M. Surgical, Inc. · 20084cite it
  • K982142Mountable Endoscopic KnifeA.M. Surgical, Inc. · 19982cite it

What has FDA decided for it lately?

  • K191771SECURE ScrewA.M. Surgical, Inc. · 2019
  • K191345Pegasus SystemA.M. Surgical, Inc. · 2019
  • K180087A.M. Surgical Intramedullary Fixation DeviceA.M. Surgical, Inc. · 2018
  • K080133Mountable Endoscopic BladeA.M. Surgical, Inc. · 2008
  • K042458A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemA.M. Surgical, Inc. · 2004
  • K982142Mountable Endoscopic KnifeA.M. Surgical, Inc. · 1998

All 6 as A.M. Surgical, Inc. →