Who else makes this device?

Name: Bi-Ostetic Blocks
Brand: Bi-Ostetic Blocks

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

Bi-Ostetic Blocks

Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted,…

Registry build 21.09.26

Bi-Ostetic is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. Bi-Ostetic is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. Bi-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Bi-Ostetic is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

2manufacturers in China registered for this device type

4catalogue numbers in this listing

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 Bi-Ostetic Blocks
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)	K023703
Record published	2016-04-10
Record revised	2020-06-19 (version 6)

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 Bi-Ostetic Blocks
Catalogue number	Size	Status
BiO-XYZ101040P		In distribution
BiO-XYZ400606P		In distribution
BiO-XYZ151505P		In distribution
BiO-XYZ202005P		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

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
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.