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Genex Putty

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K073341

by Biocomposites Ltd

Identity

Trade Name
geneX® putty FDA UDI
Generic Name
Synthetic bone graft FDA UDI
Device Name
geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. FDA UDI
Model / Reference
920-002 FDA UDI
Description
geneX® Putty consists of an inorganic framework of calcium based ions. geneX® Putty has been bioengineered to mimic human bone. It is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. geneX® Putty is a non-setting putty and is supplied sterile. FDA UDI

Identifiers

Catalog Number
920-002 FDA UDI
Primary DI / UDI-DI
15060155710164 FDA UDI
510(k) Number
K073341 FDA 510(k)FDA UDI
FDA Product Code
MQV FDA 510(k)FDA UDI
GMDN Term
Synthetic bone graft FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Genex Putty is a bone graft substitute classified as a bone void filler. It is designed to fill defects in bone that are not structurally critical to the spine or pelvis, providing a scaffold for natural bone regeneration during the healing process.

This non-setting putty is supplied in a malleable form to conform to surgical sites. It is intended for single-use and is regulated under FDA 510(k) clearance (K073341) as a substantially equivalent device to existing products in the orthopedic category. No sterility or MRI safety information is specified in the provided data.

Frequently asked questions

What types of bone defects is Genex Putty intended to address, and why is it not suitable for critical structural areas like the spine or pelvis?

Genex Putty is designed specifically to fill non-structurally critical bone defects, such as small voids or gaps in long bones or peripheral skeletal sites. It acts as a scaffold to support natural bone regeneration during healing. It is not intended for critical structural areas like the spine or pelvis because these regions require devices capable of maintaining mechanical integrity and load-bearing capacity, which Genex Putty does not provide.

How is Genex Putty supplied, and what does its malleable form mean for surgical use?

Genex Putty is supplied in a non-setting, malleable form, allowing it to be easily shaped and molded to conform to the contours of the surgical site. This flexibility simplifies application during procedures, ensuring it can fill irregular bone defects without requiring additional setting or hardening.

Is Genex Putty intended for single-use or repeated use, and what does this mean for clinical workflow?

Genex Putty is explicitly intended for single-use only. This means each package is designed for one surgical procedure, reducing the risk of cross-contamination and ensuring sterility is maintained for the patient. Clinicians should follow standard single-use protocols, including proper disposal after use.

Are there any specific storage requirements for Genex Putty, and if not, how should it be handled before surgery?

The provided data does not specify any special storage requirements for Genex Putty, such as refrigeration or protection from light. However, as a single-use, non-sterile (as per the data) medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for any manufacturer-recommended handling instructions before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: genex® Tricalcium Phosphate | Bone Healing Catalyst, genex® Bone Graft Substitute | Zimmer Biomet, GENEX PUTTY by BIOCOMPOSITES LTD. | FDA 510 (k) Summary, BIOCOMPOSITES LTD 920-010 geneX® putty - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biocomposites Ltd
FDA Applicant
Biocomposites, Ltd.

Sources (2)

  • FDA 510(k) K073341 24 fields · synced Sep 19, 2026
  • FDA UDI 15976f39-1029-40f9-9141-148be61b650c 38 fields · synced May 27, 2026