510(k) Report

FDA applicant

Theken Companies, LLC

Akron, OH5 decisions2016–20221 recall

FDA records 5 decisions for Theken Companies, LLC (Akron, OH) from 2016 to 2022: 5 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and KWY (Prosthesis, Hip, Hemi-, Femoral…). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Theken Companies”.

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 Theken Companies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12017: 12019: 22022: 1
2016high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2016high 1 (2025) · low 0 (2016)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented4decisions
  • KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 126 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 6 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.

  • K161184iNSitu Total Hip SystemTheken Companies, LLC · 20167cite it
  • K172501iNSitu Total Hip SystemTheken Companies, LLC · 20174cite it
  • K192071iNSitu Total Hip SystemTheken Companies, LLC · 20192cite it
  • K191297iNSitu Bipolar Hip SystemTheken Companies, LLC · 20191cites it

What has FDA decided for it lately?

  • K220336Mg-PSZ Ceramic Femoral HeadTheken Companies · 2022
  • K191297iNSitu Bipolar Hip SystemTheken Companies, LLC · 20191 recall
  • K192071iNSitu Total Hip SystemTheken Companies, LLC · 2019
  • K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017
  • K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016

All 4 as Theken Companies, LLC →The one decision as Theken Companies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K191297iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar…Sep 11, 2025Class II

Other applicant names beginning “Theken”

FDA records each applicant name separately; these may or may not be the same firm.

Theken Spine, LLC 23Theken Surgical,Llc 9