Genex Bone Graft Substitute

FDA UDI

Class II (US FDA UDI)

by Biocomposites Ltd

Identity

Trade Name: Genex Bone Graft Substitute FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldable cohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substitute is supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe. FDA UDI
Model / Reference: 910-005Z FDA UDI
Description: genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldable cohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set in situ or placed in the bead mould mat provided to form beads for implantation. When injected the mixture sets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substitute is supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex. genex® Bone Graft Substitute is MR safe. FDA UDI

Identifiers

Catalog Number: 910-005Z FDA UDI
Primary DI / UDI-DI: 15060155711482 FDA UDI
510(k) Number: K212721 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Synthetic bone graft

Genex Bone Graft Substitute by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K212721 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biocomposites Ltd

Sources (1)

FDA UDI 10fcfa41-0594-4293-a912-e7a6351e319c 36 fields · synced May 30, 2026