Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Jiangsu and Zhejiang: 4 hold an FDA registration.

Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is JDL Classified?

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) is FDA product code JDL, Class 3, 21 CFR 888.3320.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Packaging process control (2), Software design (manufacturing process) (1) and Process change control (1).

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

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Dome Hole Plug

Acetabular Dome Hole Plug

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Eleos™

Femoral Head, Super FINISH36MM Taper, +3.5MM 36MM, +3.5MM

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Taperloc® Microplasty®

Catalogue number 33-103201, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Arcos Modular Revision Hip System

6 catalogue numbers from 11-302015, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

KM-3A Hip System

2 catalogue numbers from 242852117, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Duracon

5 catalogue numbers from 6642-9-822, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

CLS® Brevius® Kinectiv®

CLS Brevius Kinectiv Rasp Size 13.75

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Taperloc Complete Micro Primary Femoral

2 catalogue numbers from 51-107140, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

P.C.A.

All Poly Patella

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Transcend®

Cocr Transcend® Femoral Head 32MM SLT Taper Medium Neck

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Healey HIP System

12 catalogue numbers from 11-105462, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Dynasty

Dynasty® A-Class® 54MM 15DG Group K Crosslinked Poly Liner

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Kinectiv®

3 catalogue numbers from 00-7848-021-01, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). 4 manufacturers in China are registered for this product code.

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Implant Partners

Cocr SF FEM Head 36MM SLT TPR Xlng NK Implant Partners™

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Conserve®

Conserve® A-Class® BFH® Head Medium Neck 46MM

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

S-ROM

Apical Hole Plug

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Consensus Hip System

Acetabular Shell, No Hole, Cementless, PC, 42mm

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Fitmore® Hip Stem

Fitmore®, Hip stem, uncemented, offset B (extended)/1, taper 12/14

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

CLS® Brevius™ Stem

CLS Brevius Stem with Kinectiv, Size 10

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Omnifit

10 Degree Series I Insert

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Consensus® Hip System

Femoral Stem, Collared, Tapered, Cemented

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