Who else makes this device?

Name: Orthopedic Salvage System (OSS)
Brand: Orthopedic Salvage System (OSS)

Orthopedic › ProstheticProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Orthopedic Salvage System (OSS)

3 catalogue numbers from CP111828, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

3catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWZ
Manufacturer	City	Province	Registered as	Device types
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
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
Lincotek (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	7
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54

Record

Regulatory record for Orthopedic Salvage System (OSS)
Listed by	Biomet Orthopedics, United States
FDA product code	KWZ
Device type	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3310
510(k)	K020381
Record published	2015-10-24
Record revised	2025-05-30 (version 5)

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 Orthopedic Salvage System (OSS)
Catalogue number	Size	Status
CP111828	19 CM 6 CM	In distribution
151832	14 MM	In distribution
CP111819	21 CM 8 CM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DJO Surgical	Encore Medical, L.P.	159
Instrument	Howmedica Osteonics Corp	139
ZMR®	Zimmer, Inc.	103
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Zimmer, Inc.	69
Arcos Modular Revision System	Biomet Orthopedics	66
Pinnacle	Depuy Orthopaedics, Inc.	52
System 12	Howmedica Osteonics Corp	47
Restoration	Howmedica Osteonics Corp	46
Redapt	Smith & Nephew, Inc.	43
R3	Smith & Nephew, Inc.	41
Trident	Howmedica Osteonics Corp	38
Arcos Modular Revision Hip System	Biomet Orthopedics	37

Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K021661	2002-10-25

Recalls Naming This Product

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

Recalls naming the identifiers of Orthopedic Salvage System (OSS)
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2020-11-25	Class II	Process control	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.	7428	2024-05-08
Biomet, Inc.	510(k) number	2020-04-17	Class II	Process control	Potential presence of elevated endotoxin levels that exceed the specification limit	12 units	2021-06-25
Biomet, Inc.	510(k) number	2018-10-10	Class II	Under Investigation by firm	Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as th	3 total	2020-04-28
Biomet, Inc.	510(k) number	2017-06-05	Class II	Labeling False and Misleading	Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.		2018-03-06
Biomet, Inc.	510(k) number	2017-06-05	Class II	Labeling False and Misleading	Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.		2018-03-06
Biomet, Inc.	510(k) number	2017-06-05	Class II	Labeling False and Misleading	Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.		2018-03-06
Biomet, Inc.	510(k) number	2011-11-01	Not classified	Mixed-up of materials/components	Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13×150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14×150).	3 units & 1 pending release	2012-09-10
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2009-05-19	Not classified	Process control	The retaining ring may fall out of the instrument during surgery.	387 of all products	2010-10-08
Biomet, Inc.	510(k) number	2008-05-15	Not classified	Labeling False and Misleading	Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co	14 for all products.	2008-11-03
Biomet, Inc.	510(k) number	2008-05-15	Not classified	Labeling False and Misleading	Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co	14 for all products.	2008-11-03
Biomet, Inc.	510(k) number	2008-05-15	Not classified	Labeling False and Misleading	Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co	14 for all products.	2008-11-03

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P960054	1997-06-19	S-ROM POLY-DIAL CONSTRAINED LINER	Depuy, A Johnson & Johnson Co.

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.