510(k) Report

FDA applicant

Osteotec, Ltd.

Christchurch, Dorset, GB1 decision2015–20151 recall

FDA records 1 decision for Osteotec, Ltd. (Christchurch, Dorset, GB) in 2015: 1 510(k) clearance. All are in product code KYJ (Prosthesis, Finger, Constrained, Polymer). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Osteotec, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2015high 1 (2025) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Osteotec, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KYJProsthesis, Finger, Constrained, Polymer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K140453Osteotec Silicone Finger ImplantOsteotec, Ltd. · 20151 recall

The one decision as Osteotec, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140453Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog…Jun 18, 2025Class II