Biocomposites, Ltd.
Wilmington, NC, US
BIOCOMPOSITES LTD. appears in FDA device records in Wilmington, NC. FDA records list 27 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Biocomposites, Ltd. between 2000 and 2026. The busiest year on record is 2007, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 4 |
| 2015 | 1 |
| 2022 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251680 | Biosteon® Screw | MAI | Substantially Equivalent | |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | KWL | Substantially Equivalent | |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | Substantially Equivalent | |
| K212721 | Genex Bone Graft Substitute | MQV | Substantially Equivalent | |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | MQV | Substantially Equivalent | |
| K082381 | GENEX | MQV | Substantially Equivalent | |
| K082383 | FORTOSS VITAL | LYC | Substantially Equivalent | |
| K073341 | GENEX PUTTY | MQV | Substantially Equivalent | |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K072127 | DOMINATOR | HWC | Substantially Equivalent | |
| K071952 | GRAFTLOCK SCREW, ST SCREW | HWC | Substantially Equivalent | |
| K071115 | MODIFICATION TO BILOK ST SCREW | HWC | Substantially Equivalent | |
| K071091 | MODIFICATION TO BILOK SCREW | HWC | Substantially Equivalent | |
| K061949 | DOUBLEPLAY SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K061311 | ALLOGRAN-R | MQV | Substantially Equivalent | |
| K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE | LYC | Substantially Equivalent | |
| K043514 | ALLOGRAN-N-BONE VOID FILLER | MQV | Substantially Equivalent | |
| K040265 | LITTLE GRAFTER SCREW | HWC | Substantially Equivalent | |
| K040600 | GENEX BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K033792 | BILOK ST SCREW | HWC | Substantially Equivalent | |
| K021551 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | MQV | Substantially Equivalent | |
| K021351 | BIOSTEON CROSS PIN | HWC | Substantially Equivalent | |
| K003954 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | MQV | Substantially Equivalent | |
| K003641 | BIOLOK SCREW, BIOSTEON SCREW | HWC | Substantially Equivalent | |
| K002070 | BIOLOK SCREW | HWC | Substantially Equivalent | |
| K001724 | STIMULAN -CALCIUM SULFATE BONE VOID FILTER | MQV | Substantially Equivalent | |
| K993238 | FORTOSS-CEMA | LYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617083 | 3002806534 | BIOCOMPOSITES LTD. | KEELE SCIENCE PARK, Keele Staffordshire ST5 5NL GB | 2026 | |
| 1065982 | 3003029518 | BIOCOMPOSITES, INC. | 700 Military Cutoff Rd Ste 320, Wilmington, NC 28405 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYCBone Grafting Material, Synthetic
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- LXHOrthopedic Manual Surgical Instrument
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- HWTTemplate
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0638-2021 | 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 stability of the bony structure. | The product is mislabeled. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain