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

Freedom® RingLoc® Hip System

28 catalogue numbers from 11-107023, 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
28catalogue 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 Freedom® RingLoc® 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) K030047
Record published 2015-10-24
Record revised 2025-10-07 (version 6)

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 Freedom® RingLoc® Hip System
Catalogue number Size Status
11-107023 36MM HEAD SIZE 24 LINER SIZE In distribution
11-107222 36MM HEAD SIZE 43 LINER SIZE In distribution
11-107026 36MM HEAD SIZE 27 LINER SIZE In distribution
11-107327 36MM HEAD SIZE 28 LINER SIZE In distribution
11-107227 36mm Head Size 48 Liner Size In distribution
11-107427 36MM HEAD SIZE 28 LINER SIZE In distribution
11-107025 36MM HEAD SIZE 26 LINER SIZE In distribution
11-107223 36mm Head Size 44 Liner Size In distribution
11-107227 36MM HEAD SIZE 48 LINER SIZE In distribution
11-107425 36MM HEAD SIZE 26 LINER SIZE In distribution
11-107325 36MM HEAD SIZE 26 LINER SIZE In distribution
11-107226 36MM HEAD SIZE 47 LINER SIZE In distribution
11-107226 36mm Head Size 47 Liner Size In distribution
11-107222 36mm Head Size 43 Liner Size In distribution
11-107225 36MM HEAD SIZE 46 LINER SIZE In distribution
11-107424 36MM HEAD SIZE 25 LINER SIZE In distribution
11-107224 36MM HEAD SIZE 45 LINER SIZE In distribution
11-107423 36MM HEAD SIZE 24 LINER SIZE In distribution
11-107323 36MM HEAD SIZE 24 LINER SIZE In distribution
11-107224 36mm Head Size 45 Liner Size In distribution
11-107223 36MM HEAD SIZE 44 LINER SIZE In distribution
11-107024 36MM HEAD SIZE 25 LINER SIZE In distribution
11-107022 36MM HEAD SIZE 23 LINER SIZE In distribution
11-107225 36mm Head Size 46 Liner Size In distribution
11-107027 36MM HEAD SIZE 28 LINER SIZE In distribution
11-107426 36MM HEAD SIZE 27 LINER SIZE In distribution
11-107324 36MM HEAD SIZE 25 LINER SIZE In distribution
11-107326 36MM HEAD SIZE 27 LINER SIZE 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

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.

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