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.

Registry build 21.09.26
4manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JDL
Manufacturer City Province Registered as Device types
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 KM-3A Hip System
Listed by Biomet Orthopedics, United States
FDA product code JDL
Device type Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class Class 3
Regulation 21 CFR 888.3320
510(k) K870867
Record published 2019-11-19
Record revised 2025-05-30 (version 3)

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 KM-3A Hip System
Catalogue number Size Status
242852117 28mm Inner Ø 52mm Outer Ø In distribution
242854107 28mm Inner Ø 54mm Outer Ø In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Consensus® Hip System Consensus Orthopedics, Inc. 57
Consensus Hip System Shalby Advanced Technologies, Inc. 57
Omnifit Howmedica Osteonics Corp 29
Conserve® Microport Orthopedics Inc. 20
Fitmore® Hip Stem Zimmer, Inc. 19
Dynasty Microport Orthopedics Inc. 12
Healey HIP System Biomet Orthopedics 12
Transcend® Microport Orthopedics Inc. 6
CLS® Brevius® Kinectiv® Zimmer, Inc. 6
Arcos Modular Revision Hip System Biomet Orthopedics 6
Duracon Howmedica Osteonics Corp 5
Kinectiv® Zimmer, Inc. 3

Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

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.

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