Who else makes this device?

Name: G7 Type 12 / 14 Provisional Head
Brand: G7 Type 12 / 14 Provisional Head

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

G7 Type 12 / 14 Provisional Head

Catalogue number 010002540, 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

1catalogue number

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 G7 Type 12 / 14 Provisional Head
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)	K121874
Record published	2016-10-26
Record revised	2025-05-30 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for G7 Type 12 / 14 Provisional Head
Catalogue number	Size	Status
010002540	36MM, STD NECK LENGTH	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 G7 Type 12 / 14 Provisional Head
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Zimmer, Inc.	510(k) number	2022-08-25	Class II	Under Investigation by firm	The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery	56 US
Biomet, Inc.	510(k) number	2014-05-07	Class II	Use error	Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.	1047 total	2015-10-30
Biomet, Inc.	510(k) number	2014-05-07	Class II	Use error	Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.	1047 total	2015-10-30

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.