Biocomposites, Ltd. - FDA 510(k) Cleared Devices

Biocomposites, Ltd. is an international medical device manufacturer based in Keele, GB. The company engineers and manufactures specialized devices for musculoskeletal infection, trauma, spine, and orthopedic applications.

Biocomposites has received 27 FDA 510(k) clearances from 27 total submissions since 2000. The company's portfolio is dominated by Orthopedic devices, which represent 89% of its regulatory submissions. The latest FDA 510(k) clearance was granted in 2026, confirming active regulatory engagement.

The company's core product lines include antibiotic-loaded bone cements and spacers under the SYNICEM™ brand, calcium matrix antibiotic carriers such as STIMULAN®, and bone graft substitutes including NanoBone® and genex®. These devices address infection management, joint revision, and bone regeneration across foot and ankle, spine, and trauma specialties.

Explore the full regulatory record, including device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Bruder Consulting & Venture Group as regulatory consultant.