Who else makes this device?

Name: Oxinium
Brand: Oxinium

Oxinium · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous → Orthopedic

5manufacturers in China registered for this device type

2catalogue numbers in this listing

9510(k) clearances naming this product code

9recalls on this code

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MBL
Manufacturer	City	Province	Registered as	Device types
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Oxinium
Listed by	Smith & Nephew, Inc., United States
FDA product code	MBL
Device type	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device class	Class 2
Regulation	21 CFR 888.3358
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K093363
Record published	2015-08-30
Record revised	2025-11-27 (version 8)

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

Catalogue Numbers

Catalogue numbers for Oxinium
Catalogue number	Size	Status
71342344		In distribution
71342340		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
R3	Smith & Nephew, Inc.	177
Instrument	Howmedica Osteonics Corp	100
Reflection	Smith & Nephew, Inc.	89
Profemur®	Microport Orthopedics Inc.	53
Delta	Limacorporate	44
Onvoy	Globus Medical, Inc.	40
Restoration	Howmedica Osteonics Corp	39
Dynasty	Microport Orthopedics Inc.	28
Delta Liners & Accessories	Limacorporate	27
R3, Stiktite	Smith & Nephew, Inc.	26
Biolox Delta	Limacorporate	19
Tri-plus	Ortho Development Corp.	16

Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K201701	2020-10-06
K182535	2018-11-19
K161233	2016-12-14
K113848	2012-04-27
K102370	2011-01-19
K093363	2010-01-26
K092386	2009-11-03
K070756	2007-06-06
K061253	2006-05-31

Recalls

9 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	Closed
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	1766 devices
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	58 devices
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	6468 devices
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	4172 devices
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	1267 devices
2020-04-22	Class II	Process control	A manufacturing error resulted in out of specification R3 Acetabular Shells	1450 devices
2014-01-23	Class II	Under Investigation by firm	Inner spherical radius of the shell is undersized.	10 units	2016-11-15
2013-05-29	Class II	Packaging process control	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.	53 units	2016-03-22
2013-05-29	Class II	Packaging process control	One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.	53 units	2016-03-22

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.

Oxinium