Who else makes this device?

Name: Balance HIP System
Brand: Balance HIP System

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

Balance HIP System

3 catalogue numbers from 180017, 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 Balance HIP System
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)	K030055
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 Balance HIP System
Catalogue number	Size	Status
180017	15 SIZE 180 MM TYPE1 TAPER	In distribution
180004	9 SIZE 150 MM TYPE1 TAPER	In distribution
180021	17 SIZE 180 MM TYPE1 TAPER	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

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

Recalls naming the identifiers of Balance HIP System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2019-08-21	Class II	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.	219988 units (total)	2021-07-21
Biomet, Inc.	510(k) number	2015-04-16	Class III	Labeling mix-ups	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.	1315	2016-05-16
Biomet, Inc.	510(k) number	2015-01-09	Class II	Packaging process control	Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.	17	2015-10-22

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.