Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Who Makes This Device Type in China?

4 of the 6 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, Zhejiang and Guangdong, and 1 other province.

Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Turnxon Precision Co., Ltd. Guangdong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is HSX Classified?

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer is FDA product code HSX, Class 2, 21 CFR 888.3520.

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 104 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Device Design (45), Labeling design (32) and Process control (6).

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

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – D, 7

Catalogue number 121-26-1427, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – B, 6

Catalogue number 121-26-1216, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – C, 5

Catalogue number 121-26-1325, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – F, 9

Catalogue number 121-26-1629, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – E, 7

Catalogue number 121-26-1527, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – A, 5

Catalogue number 121-26-1115, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Femoral Component – Medium

Catalogue number 121-26-2300, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – B, 8

Catalogue number 121-26-1228, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Trigen

Mini Connector

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – D, 8

Catalogue number 121-26-1428, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – D, 5

Catalogue number 121-26-1425, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – A, 7

Catalogue number 121-26-1117, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

BC Reflex Uni Reusable Surgical Instrument Set

Reusable Surgical Instrument Set

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – A, 9

Catalogue number 121-26-1129, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Iuni Ipoly Implant

IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

CHS

Quick Connect Adapter FOR Hall Jacobs Stryker Power

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – C, 8

Catalogue number 121-26-1318, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – B, 5

Catalogue number 121-26-1215, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – F, 6

Catalogue number 121-26-1626, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Iuni® Tibial Kit

Catalogue number RUK101111302, listed by ConforMIS, Inc., United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – D, 7

Catalogue number 121-26-1417, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – F, 8

Catalogue number 121-26-1628, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – D, 8

Catalogue number 121-26-1418, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm. C, 7

Catalogue number 121-26-1317, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – A, 9

Catalogue number 121-26-1119, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – D, 5

Catalogue number 121-26-1415, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – C, 5

Catalogue number 121-26-1315, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – F, 7

Catalogue number 121-26-1627, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Iuni® Femoral Kit

2 catalogue numbers from RUK101111203, listed by ConforMIS, Inc., United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

AML TRI-Lock

AML TRI-LOCK REPLACEMENT LINER STANDARD PROFILE 32mm ID 50mm OD

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – E, 7

Catalogue number 121-26-1517, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rllm – A, 6

Catalogue number 121-26-1116, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Stride Unicondylar Kne

STRIDE Tibial Tray Implant SIZE 7 LM/RL

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Zimmer Biomet Patient Specific Instruments

MRI Zimmer Guide and Bone Model for Partial Knee Arthroplasty

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Large Cannulated Screws

Chuck Adapter Hall Jacobs Male TO Large AO

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cambridge Partial Knee Tibial Component, Rmll – E, 9

Catalogue number 121-26-1529, listed by Signature Orthopaedics PTY Limited, Australia, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Specialty Triathlon TS Cutting Guide Size 6

Catalogue number I-K4275CG06, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer. 6 manufacturers in China are registered for this product code.

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Anthology

EM Extension ROD

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

ACS ENDURON POLYETHYLENE ACETABULAR LINER 20 DEGREE 28mm ID GROUP 4

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Who Makes This Device Type in China?

How Is HSX Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies