Who else makes this device?

Name: Synthetic Backfill Bioimplant Ø6.5 x 40mm
Brand: Synthetic Backfill Bioimplant Ø6.5 x 40mm

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Synthetic Backfill Bioimplant Ø6.5 X 40mm

The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with…

Registry build 21.09.26

The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.

2manufacturers in China registered for this device type

1catalogue number

14510(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 Synthetic Backfill Bioimplant Ø6.5 x 40mm
Listed by	Berkeley Advanced Biomaterials, United States
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Manufacturer
510(k)	K170917
Record published	2024-04-24

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, serial number

Catalogue Numbers

Catalogue numbers for Synthetic Backfill Bioimplant Ø6.5 x 40mm
Catalogue number	Size	Status
MSBG6540		In distribution

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
K170917	2017-10-30
K113791	2012-03-15
K091912	2010-06-23
K092046	2010-03-24
K053213	2006-07-06
K051914	2005-11-03
K051695	2005-07-19
K050666	2005-04-11
K042636	2004-12-14
K041889	2004-08-19
K040405	2004-03-05
K030266	2003-02-20
K023703	2003-01-30
K022622	2003-01-09

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Synthetic Backfill Bioimplant Ø6.5 x 40mm
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Berkeley Advanced Biomaterials	510(k) number	2025-09-02	Class II	Process control	Due to incorrect product label (Incorrect product name identified on outer packaging).	62 units

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.