510(k) Report

FDA applicant

Surgtech, Inc.

Westlake, OH6 decisions2016–20190 recalls

FDA records 6 decisions for Surgtech, Inc. (Westlake, OH) from 2016 to 2019: 6 510(k) clearances. Most are in product codes KWY (Prosthesis, Hip, Hemi-, Femoral…) and JDI (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 53 predicates, 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 Surgtech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12017: 32018: 12019: 1
2016high 3 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Surgtech, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgtech, Inc.’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?

  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision
  • HWCScrew, Fixation, Bone1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 219 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 53 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K161894SurgTech Trauma SystemSurgtech, Inc. · 20171cites it

What has FDA decided for it lately?

  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  • K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017
  • K152200SurgTech Interbody SystemSurgtech, Inc. · 2016

All 6 as Surgtech, Inc. →