Prosthesis, Hip, Hemi-, Femoral, Metal

Who Makes This Device Type in China?

6 of the 10 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Shanghai and Zhejiang, and 1 other province.

Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
Stryker (Suzhou) Medical Technology Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Xian Airfoil Technology Co., Ltd. Shaanxi, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is KWL Classified?

Prosthesis, Hip, Hemi-, Femoral, Metal is FDA product code KWL, Class 2, 21 CFR 888.3360.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 51 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (38), Employee error (3) and Mixed-up of materials/components (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 47

Catalogue number 10183, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 50mm

Catalogue number 18142, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo SH 43

Catalogue number 10190, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 44mm

Catalogue number 18136, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo SH 49

Catalogue number 10193, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 45mm

Catalogue number 18137, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Interspace GV Hip Spacer 46 XL

Catalogue number IHGV46L, listed by Tecres SPA, Italy, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 53mm

Catalogue number 18145, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

B-P Internal Fixation Accessories

B-P Modular Extension Screw W/O Ultracoat

Prosthesis, Hip, Hemi-, Femoral, Metal

Taperloc Complete XR 123 Femoral

2 catalogue numbers from 51-102070, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Mainbody, RHS, XS

Catalogue number 2215-3400, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 51

Catalogue number 10185, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Restoration ADM X3 Insert

Catalogue number 7236-2-856, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Baseplate, #0

Catalogue number 2215-1400, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 59mm

Catalogue number 18151, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Baseplate, #3

Catalogue number 2215-1430, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 56mm

Catalogue number 18148, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 38

Catalogue number 10179, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Profemur

Profemur® Gladiator® Cemented Classic Stem Size 8 Extended

Prosthesis, Hip, Hemi-, Femoral, Metal

Trochanteric Claw

"UNITED" USTAR II Hip System

Prosthesis, Hip, Hemi-, Femoral, Metal

Tritanium

Catalogue number 502-03-56E, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Mainbody, RHS, S

Catalogue number 2215-3410, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 41mm

Catalogue number 18133, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Baseplate, #2

Catalogue number 2215-1420, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 42mm

Catalogue number 18134, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Taperloc® Microplasty® Complete

4 catalogue numbers from 51-208050, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Citation

2 catalogue numbers from 6265-5109, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 53

Catalogue number 10186, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Baseplate, #4

Catalogue number 2215-1440, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 48mm

Catalogue number 18140, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 57mm

Catalogue number 18149, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Echo BI-Metric Microplasty HIP System

4 catalogue numbers from 193018, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Tibial Baseplate, #6

Catalogue number 2215-1460, listed by United Orthopedic Corp., Taiwan, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 39mm

Catalogue number 18131, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Interspace GV Hip Spacer 54

Catalogue number IHGV54S, listed by Tecres SPA, Italy, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Interspace GV Hip Spacer 60

Catalogue number IHGV60S, listed by Tecres SPA, Italy, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo SH 38

Catalogue number 10188, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BIO-Moore HIP System

2 catalogue numbers from 139020, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 49

Catalogue number 10184, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Remedy Poly+Plus Acetabular Cup

REMEDY® Poly+Plus Acetabular Cup – 44mm ID/ 52mm OD

Prosthesis, Hip, Hemi-, Femoral, Metal

RX90 HIP System

2 catalogue numbers from 149022, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 55

Catalogue number 10187, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Echo® Bi-Metric® Microplasty® Hip Stem

2 catalogue numbers from 110025760, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Screw

Hex Drive Self-Tapping Screw

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 47mm

Catalogue number 18139, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo MD 41

Catalogue number 10180, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

BioPro Bipolar Head 51mm

Catalogue number 18143, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Prosthesis, Hip, Hemi-, Femoral, Metal

Endo SH 47

Catalogue number 10192, listed by Biopro, Inc., United States, under Prosthesis, Hip, Hemi-, Femoral, Metal. 10 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer