Who else makes this device?

Name: ReBOSSIS QDS
Brand: ReBOSSIS QDS

Orthopedic › ProstheticFiller, Bone Void, Calcium Compound

ReBOSSIS QDS

ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium…

Registry build 21.09.26

ReBOSSIS QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ReBOSSIS QDS results in a cotton-like physical form. Due to its physical form, ReBOSSIS QDS is flexible and can easily fill defects in appropriate amounts.

2manufacturers in China registered for this device type

2catalogue numbers in this listing

4510(k) clearances naming this product code

2recalls 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 ReBOSSIS QDS
Listed by	Orthorebirth Co., Ltd., Japan
FDA product code	MQV
Device type	Filler, Bone Void, Calcium Compound
Device class	Class 2
Regulation	21 CFR 888.3045
Establishment	Specification developer, Manufacturer, Exporter
Record published	2018-05-30
Record revised	2024-03-25 (version 4)

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 up to 25 °C; Special storage condition: Store in a dry place
Sizes	Total volume 2 to 4 ml
Distribution end date	2019-10-31

Catalogue Numbers

Catalogue numbers for ReBOSSIS QDS
Catalogue number	Size	Status
0.25g	Total Volume 2 ml	In distribution
0.5g	Total Volume 4 ml	Withdrawn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
K240453	2024-03-04
K172573	2017-12-15
K170620	2017-06-23
K142090	2014-10-29

Recalls

2 of these are 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
2026-03-25	Class II	Device Design	Resorbable bone void filler falls outside standard specifications.	20
2026-03-25	Class II	Device Design	Resorbable bone void filler falls outside standard specifications.	1266

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.