Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biocomposites with 27 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 17, 2026: Biosteon® Screw.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 17, 2026 | Biosteon® ScrewK251680 · MAI | 510(k) clearances |
| Jun 12, 2025 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerK242865 · KWL | 510(k) clearances |
| Apr 7, 2025 | NanoBone® SBX Putty ; NanoBone® QDK250521 · MQV | 510(k) clearances |
| Feb 4, 2022 | Genex Bone Graft SubstituteK212721 · MQV | 510(k) clearances |
| Nov 12, 2020 | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the staClass II · The product is mislabeled. | Device recalls |
| Jan 23, 2015 | STIMULAN KIT, STIMULAN RAPID CUREK141830 · MQV | 510(k) clearances |
| Nov 14, 2008 | GENEXK082381 · MQV | 510(k) clearances |
| Sep 5, 2008 | FORTOSS VITALK082383 · LYC | 510(k) clearances |
| Jul 9, 2008 | GENEX PUTTYK073341 · MQV | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
