510(k) Report

FDA applicant

Biocomposites, Ltd.

Keele, GB27 decisions2000–20262 recalls

FDA records 27 decisions for Biocomposites, Ltd. (Keele, GB) from 2000 to 2026: 27 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and MQV (Filler, Bone Void, Calcium Compound). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 63 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 7 of them its own earlier devices. 2 recalls are 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 Biocomposites, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 42008: 42015: 12022: 12025: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biocomposites, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biocomposites, 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?

  • HWCScrew, Fixation, Bone11decisions
  • MQVFiller, Bone Void, Calcium Compound11decisions
  • LYCBone Grafting Material, Synthetic3decisions
  • KWLProsthesis, Hip, Hemi-, Femoral, Metal1decision
  • MAIFastener, Fixation, Biodegradable, Soft Tissue1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 212 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 63 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 26 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 7 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.

  • K002070Biolok ScrewBiocomposites, Ltd. · 20006cite it
  • K003641Biolok Screw, Biosteon ScrewBiocomposites, Ltd. · 20014cite it
  • K021551Stimulan - Calcium Sulfate Bone Void Filler KitBiocomposites, Ltd. · 20022cite it
  • K141830Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 20152cite it
  • K021351Biosteon Cross PinBiocomposites, Ltd. · 20021cites it
  • K003954Stimulan - Calcium Sulfate Bone Void Filler KitBiocomposites, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026
  • K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd. · 2025
  • K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd. · 2025
  • K212721Genex Bone Graft SubstituteBiocomposites, Ltd. · 2022
  • K141830Stimulan Kit, Stimulan Rapid CureBiocomposites, Ltd. · 20151 recall
  • K082381GENEXBiocomposites, Ltd. · 2008
  • K082383Fortoss VitalBiocomposites, Ltd. · 2008
  • K073341Genex PuttyBiocomposites, Ltd. · 2008

All 27 as Biocomposites, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K141830Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler…Nov 12, 2020Class II
  • K021351Biosteon brand HA/PLLA Cross Pin, Model Number 234-500-350; Product is distributed by…Aug 23, 2005