Medical Device Manufacturer · GB , Keele

Biocomposites, Ltd.

27 submissions · 27 cleared · Since 2000
27
Total
27
Cleared
0
Denied

Biocomposites, Ltd. — FDA 510(k) Submissions

Biocomposites, Ltd. has submitted 27 FDA 510(k) premarket notifications since 2000, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Filler, Bone Void, Calcium Compound, Screw, Fixation, Bone, Bone Grafting Material, Synthetic, Prosthesis, Hip, Hemi-, Femoral, Metal, Fastener, Fixation, Biodegradable, Soft Tissue . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
Biosteon? Screw
K251680 · MAI Fastener, Fixation,... · Orthopedic
Feb 2026 263d
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
K242865 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Jun 2025 265d
NanoBone? SBX Putty ; NanoBone? QD
K250521 · MQV Filler, Bone Void,... · Orthopedic
Apr 2025 45d
Genex Bone Graft Substitute
K212721 · MQV Filler, Bone Void,... · Orthopedic
Feb 2022 161d
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · MQV Filler, Bone Void,... · Orthopedic
Jan 2015 200d
GENEX
K082381 · MQV Filler, Bone Void,... · Orthopedic
Nov 2008 87d
FORTOSS VITAL
K082383 · LYC Bone Grafting Material,... · Dental
Sep 2008 17d
GENEX PUTTY
K073341 · MQV Filler, Bone Void,... · Orthopedic
Jul 2008 224d
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428 · HWC Screw, Fixation, Bone · Orthopedic
Jun 2008 30d
DOMINATOR
K072127 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2007 29d
GRAFTLOCK SCREW, ST SCREW
K071952 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2007 29d
MODIFICATION TO BILOK SCREW
K071091 · HWC Screw, Fixation, Bone · Orthopedic
May 2007 29d
MODIFICATION TO BILOK ST SCREW
K071115 · HWC Screw, Fixation, Bone · Orthopedic
May 2007 27d
DOUBLEPLAY SUTURE ANCHOR
K061949 · HWC Screw, Fixation, Bone · Orthopedic
Sep 2006 77d
ALLOGRAN-R
K061311 · MQV Filler, Bone Void,... · Orthopedic
Sep 2006 135d
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · LYC Bone Grafting Material,... · Dental
Aug 2005 212d
ALLOGRAN-N-BONE VOID FILLER
K043514 · MQV Filler, Bone Void,... · Orthopedic
Jan 2005 32d
LITTLE GRAFTER SCREW
K040265 · HWC Screw, Fixation, Bone · Orthopedic
May 2004 113d
GENEX BONE GRAFT SUBSTITUTE
K040600 · MQV Filler, Bone Void,... · Orthopedic
May 2004 60d
BILOK ST SCREW
K033792 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2004 87d
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV Filler, Bone Void,... · Orthopedic
Nov 2002 172d
BIOSTEON CROSS PIN
K021351 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2002 171d
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV Filler, Bone Void,... · Orthopedic
Jul 2001 203d
BIOLOK SCREW, BIOSTEON SCREW
K003641 · HWC Screw, Fixation, Bone · Orthopedic
Feb 2001 73d
BIOLOK SCREW
K002070 · HWC Screw, Fixation, Bone · Orthopedic
Aug 2000 49d
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