510(k) Report

FDA applicant

Tcm Associates, Ltd.

Naseing Essex, GB1 decision2015–20150 recalls

FDA records 1 decision for Tcm Associates, Ltd. (Naseing Essex, GB) in 2015: 1 510(k) clearance. All are in product code MQV (Filler, Bone Void, Calcium Compound). Its devices cite 3 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 Tcm Associates, 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

No recall linked to its devices since 2015.

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

Planning a device like Tcm Associates, Ltd.’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?

  • MQVFiller, Bone Void, Calcium Compound1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K143692GranOSTM - beta tricalcium phosphate synthetic bone granulesTcm Associates, Ltd. · 2015

The one decision as Tcm Associates, Ltd. →