Data / Medical devices / United Kingdom / Biocomposites Ltd.
Biocomposites Ltd.: FDA-registered device maker in Keele Staffordshire, United Kingdom, 9 510(k) clearances
Biocomposites Ltd. is registered with the FDA (registration 9617083) in Keele Staffordshire, United Kingdom. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 12, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9617083
- FEI number
- 3002806534
- Address
- Keele Science Park, Keele Staffordshire, United Kingdom, ST5 5NL
- Owner or operator
- BIOCOMPOSITES LTD. (9032315)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 1, 2007
- Registered through
- 2027
- Brand names listed
- Allogran-R, Fx Fade Screw, Genex, Genex Bone Graft Substtute, Genex Putty, Little Grafter Screw, Stimulan Kit Stimulan Rapid Cure, Synicem Hip Spacer with Gentamicin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 2 | Specification developer | accessdata.fda.gov |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 2 | Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2025 | K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | KWL | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| February 4, 2022 | K212721 | Genex Bone Graft Substitute | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| January 23, 2015 | K141830 | STIMULAN KIT, STIMULAN RAPID CURE | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| November 14, 2008 | K082381 | GENEX | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| July 9, 2008 | K073341 | GENEX PUTTY | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| August 31, 2007 | K072127 | DOMINATOR | HWC | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| September 22, 2006 | K061311 | ALLOGRAN-R | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| May 28, 2004 | K040265 | LITTLE GRAFTER SCREW | HWC | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| February 8, 2001 | K003641 | BIOLOK SCREW, BIOSTEON SCREW | HWC | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 12, 2020 | 86755 | Class II | Terminated | Stimulan Kit 10cc, Model - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. | The product is mislabeled. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Filler, Bone Void, Calcium Compound
Updated June 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.