Who else makes this device?

Name: geneX® ds
Brand: geneX® ds

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Genex® Ds

geneX® 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…

Registry build 21.09.26

geneX® 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. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX®; a hard but resorbable matrix.

2manufacturers in China registered for this device type

6catalogue numbers in this listing

11510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1).

Chinese manufacturers registered for FDA product code MQV
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Allgens Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	1

Record

Regulatory record for geneX® ds
Listed by	Biocomposites Ltd., United Kingdom
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Specification developer, Manufacturer
Record published	2020-01-07
Record revised	2020-11-02 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 4 to 45 °C; Storage environment temperature 39 to 113 °F
Distribution end date	2020-01-02

Catalogue Numbers

Catalogue numbers for geneX® ds
Catalogue number	Size	Status
980-002	2.5cc	In distribution
980-005	5cc	In distribution
11-2005	5cc	Withdrawn
980-002	2.5cc	Withdrawn
980-005	5cc	Withdrawn
11-2002	2.5cc	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Synthacer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	360
Syntricer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	357
Biosorb	S.B.M	65
MagnetOs	Kuros Biosciences B.V	61
BioSet®	Rti Surgical, Inc.	47
Bicera® Resorbable Bone Substitute	Wiltrom Corporation Limited	41
GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM)	Medtronic Sofamor Danek, Inc.	40
Bicera® Resorbable Bone Substitute	Wiltrom Co., Ltd. (Chutung)	39
ChronOS	Synthes Gmbh	39
Synthacer/Syntricer	medArtis Medizinprodukte und Forschung Aktiengesellschaft	36
Inion BioRestore™	Inion OY	35
Resorba Synthetic Bone	Biomatlante	35

Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K250521	2025-04-07
K212721	2022-02-04
K141830	2015-01-23
K082381	2008-11-14
K073341	2008-07-09
K061311	2006-09-22
K043514	2005-01-21
K040600	2004-05-07
K021551	2002-11-01
K003954	2001-07-12
K001724	2000-08-04

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-11-12	Class II	Labeling mix-ups	The product is mislabeled.	54 boxes	2021-04-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.