BIOCOMPOSITES LTD.

FDA Device Registration & Listing · Keele Staffordshire, GB · Registration 9617083

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9617083
FEI Number
3002806534
Entity Name
BIOCOMPOSITES LTD.
City/State/Country
Keele Staffordshire, GB
Establishment Address
KEELE SCIENCE PARK, Keele Staffordshire ST5 5NL, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIOCOMPOSITES LTD. (Owner Number: 9032315)
Owner / Operator Contact Address
Keele Science Park, --, Keele, GB-STS ST5 5NL, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K073341
PMA Number
N/A

All Registered Proprietary Names

Stimulan Kit Stimulan Rapid Cure Synicem Knee Spacer with Gentamicin Synicem Hip Spacer with Gentamicin Synicem Shoulder Spacer with Gentamicin Allogran-R Fx Fade™ Screw Little Grafter Screw Genex Bone Graft Substtute Genex Putty

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-03-04
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-07-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-07-04
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-07-04
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2025-07-04
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-07-04
HWT Template Orthopedic Class 1 888.4800 2025-07-15
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2007-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-11-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2007-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-11-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-11-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-02-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-07-16

Official Correspondent

Ciara Airey

US Agent Details

Kathleen Moon Business: BIOCOMPOSITES, INC. Email: akm@biocomposites.com Phone: (910) 3508015

Related Public Records

Same Entity

BIOCOMPOSITES LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K823482 Intermedics Orthopedics 101 UNIVERSAL ENDOPROSTHESIS 1983-02-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617083. Last updated year: 2026. Please use registration number 9617083 when referencing this establishment in official correspondence.
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