Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shanghai and Guangdong, and 1 other province: 8 hold an FDA registration. 2 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Arthrex (Shanghai) Co., Ltd. Shanghai
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
Paragon Medical Device (Changzhou) 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

What Is FDA Product Code HSD?

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented is FDA product code HSD, Class 2, 21 CFR 888.3690.

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 19 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are No Marketing Application (5), Package design/selection (2) and Nonconforming Material/Component (2).

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

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR Shoulder

SMR Shoulder - Glenosph. Dia. 42-Ecc.42 Extract. Insert

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humelock II Cementless Shoulder System

Humelock II Cementless is a humeral stem range used in a hemi-shoulder replacement. The stem fits into the upper arm bone and connects through a double-taper adapter to the humeral head,…

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Titan Modular Shoulder System 2.5

TSS Cocr Concentric Head. 2.5 50X22MM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Flex Shoulder System

13 catalogue numbers from DWF343, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

TI Humeral Stem HA Coated Press-FIT Size 14/135MM-STER

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Bigliani/Flatow®

86 catalogue numbers from 4303-52-18, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

HemiCAPOVO®

Humeral Component, 58mm x 54mm, OVO

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Anatomical Shoulder™ Bigliani/Flatow®

AS B/F Provisional Adaptor 42°

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Prima

PRIMA - Anatomic Back Table Assembly Block Plus #6

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Perform™ Humeral System

23 catalogue numbers from DWX1SS, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Trabecular Metal Reverse Plus™

18 catalogue numbers from 00-4361-041-01, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Equinoxe

Glenoid, Posterior Augment Pegged, 8 degree, Cemented Right

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Link Embrace Shoulder System

Bone Screws, and Central Cancellous Bone Screw, Ca

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Tornier Flex Shoulder System

14 catalogue numbers from DWF392A, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Shoulder Innovations TSA

Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Steel

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Titan™ Total Shoulder System

The Titan Modular Total Shoulder System Pegged Glenoid is used in conjunction with metaphyseal bodies, humeral stems, and humeral heads in the TITAN™ Modular Total Shoulder System for total…

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

HemiCAP®

Art. Comp., 40mm, .1875 Post, 10.5mm x 10.5mm CE

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Trabecular Metal®

90 catalogue numbers from 00-4349-012-13, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR System

SMR System - Humeral Head Dia. 40 mm H. 12 mm Eccentrical 2mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR Shoulder System

Glenoid Reamer for Humeral Head Dia. 52 mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR Stemless

SMR STEMLESS - Reamer Shaft

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Intermediary Punch Holder

Catalogue number 261104, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Global Unite

Global Unite Platform Shoulder System Reverse FX EPI Center Porocoat

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Tornier HRS

43 catalogue numbers from ARS741801, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humelock Reversed Shoulder

HEX. 3,5 Screw TA6V FOR Offset Modular System

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Integra®

Humeral Resurfacing Arthroplasty

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Affiniti™

25 catalogue numbers from 0020015, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Ascend™

21 catalogue numbers from 503305A, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Arthrex®

Univers II Humeral Cuff Tear Arthropathy

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Delta Xtend

DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +10mm HA COATED CEMENTLESS

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Comprehensive® Shoulder System

85 catalogue numbers from 113648, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Acumed

Modular Shoulder Body Assy., 13mm, Right

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Aequalis Press-FIT

12 catalogue numbers from DWB733, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Anatomical Shoulder™

A.S. Humeral stem Rev. 12 cemented

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

DJO Surgical

Altivate Reverse, Small Socket Insert, 36MM Semi Constrained

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR Resurfacing System

Spherical Reamer Dia.42-44mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Promos

Promos Reverse Fixation Screw Inserter

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Trial Screw

6 catalogue numbers from 78210035, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Aequalis

16 catalogue numbers from DWA248, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humeris Shoulder

HUMERIS STEM TA6V SIZE 17 CEMENTLESS Ti/HA

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Jarvis Diaphyseal Stem Standard

18 catalogue numbers from 272343 - JARVIS DIAPHYSEAL STEM STANDARD, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Global CAP

GLOBAL CAP HEAD DUOFIX HA PC SIZE 40 x 18

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humelock II Cemented Shoulder System

Humelock II Cemented Shoulder System, HUMELOCK II LONG STEM TA6V SIZE 11 LG200 mm CEMENTED

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humelock II Cemented Reversible Shoulder

HUMELOCK REVERSED TRIAL ECCENTRIC GLENOSPHERE 10° TILT Ø32 mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Metaphyseal Component Omarthrosis

10 catalogue numbers from 3821006200, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Aequalis™ Fx2

33 catalogue numbers from DWH413B, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Metaphyseal Component Trauma

5 catalogue numbers from 3821000100, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon®

metaphyseal component omarthrosis incl. safety screw

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Glenoid Baseplate With Screw

HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FX V135

Stability Trial CUP 135°/145° FOR Implant FX V 135 Ø32 + 12

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Affiniti™ PC

7 catalogue numbers from 1122235, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Comprehensive® Shoulder Instruments

12 catalogue numbers from 41-406813, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FX Solutions

Humelock II Cemented Shoulder System, HUMELOCK II STEM TA6V SIZE 13 CEMENTED

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cancellous Screw

5 catalogue numbers from 57934028, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Humelock Reversed

Trial Eccentric Taper Adapter Ø24 / Ø10

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Centered Humeral Trail Head Ø54 H21

Catalogue number 261040, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

BIO-Modular Shoulder System

40 catalogue numbers from CP550641, listed by Biomet Orthopedics, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Global AP

GLOBAL AP HUMERAL HEAD ECCENTRIC SIZE 44 x 15

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Metaphyseal Component Omarthrosis Incl. Safety Screw

10 catalogue numbers from 38210052, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Metaphyseal Component Trauma Incl. Safety Screw

5 catalogue numbers from 38210071, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Solar

Shoulder Humeral Offset Head

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® XO CTA Cap

12 catalogue numbers from 38625314, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Glenoide Shoulder

Glenoid Pressure - SMR Shoulder

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Arrow®

21 catalogue numbers from 265109 - CoCr CENTRED HUMERAL HEAD, Ø44 , listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Aequalis™ Adjustable Reversed

Standard Locking Screw

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Trigen

Scupltor Flexible With Circular Connector

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cofield

Modified C2 Glen Keel Cutter F/USE W/Angle Driver

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Aequalis Reversed II

5 catalogue numbers from DWH904, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® XO Retentive Trial Cap

9 catalogue numbers from 78213210, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Affiniti™ EH²

8 catalogue numbers from 0020083, listed by Tornier Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Anatomical Shoulder™ Combined

AS™ B/F® adaptor 45°

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Screw Holder

Catalogue number 261108, listed by Fournitures Hospitalieres Industrie, United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Reunion

Cannulated TSA Half-Moon Reamer Size 56

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

SMR

SMR : HEMISPHERICAL HUMERAL REAMER Ø54mm

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Tornier Perform™ Humeral System

Fracture Humeral Head Coupler

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Shoulder Innovations TSA System

TSA - Augmented Glenoid Trial 20MM X 10°

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Agilon® Trial Extension Piece

5 catalogue numbers from 78210150, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Identity™

28 catalogue numbers from SBHS6106, listed by Zimmer, Inc., United States, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cancellous Screw Angle Stable

16 catalogue numbers from 57944212, listed by implantcast GmbH, Germany, under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented. 8 manufacturers in China are registered for this product code.

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Doane Knee Retractor Large Blades 63.5MM X 76.2MM

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Which Manufacturers in China Make This?

What Is FDA Product Code HSD?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies