Who else makes this device?

Name: Collage Osteoconductive Scaffold - Putty
Brand: Collage Osteoconductive Scaffold - Putty

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Collage Osteoconductive Scaffold – Putty

The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity…

Registry build 21.09.26

The Orthofix Collage Osteoconductive Scaffold – Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.

2manufacturers in China registered for this device type

6catalogue numbers in this listing

3510(k) clearances naming this product code

4recalls on this code

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 Collage Osteoconductive Scaffold – Putty
Listed by	Integra Lifesciences Corporation, United States
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K062353
Record published	2015-09-22
Record revised	2023-08-15 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature 10 to 25 °C
Distribution end date	2023-07-31

Catalogue Numbers

Catalogue numbers for Collage Osteoconductive Scaffold – Putty
Catalogue number	Size	Status
710010	10 cc	Withdrawn
710010	10 cc	Withdrawn
710015	15 cc	Withdrawn
710005	5 cc	Withdrawn
710005	5 cc	Withdrawn
710015	15 cc	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
K091302	2009-12-04
K063124	2007-01-19
K062353	2006-12-20

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Collage Osteoconductive Scaffold – Putty
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Integra Lifesciences Corporation	510(k) number	2011-10-11	Class II	Employee error	The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term “bone marrow aspirate”. The term is incorrectly tran	42 units	2013-02-14
Integra Lifesciences Corporation	510(k) number	2011-10-07	Not classified	Error in labeling	Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.	45 units	2013-05-21
Integra Lifesciences Corporation	510(k) number	2009-01-16	Not classified	Pending	Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.	88 units	2009-06-25

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
2011-10-11	Class II	Employee error	The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term “bone marrow aspirate”. The term is incorrectly transl	22 units	2013-02-14

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.