Prosthesis, Hip, Femoral Component, Cemented, Metal

Who Makes This Device Type in China?

3 of the 5 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, Shanghai and Zhejiang.

Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Suzhou Ahno Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is JDG Classified?

Prosthesis, Hip, Femoral Component, Cemented, Metal is FDA product code JDG, Class 2, 21 CFR 888.3360.

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 18 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Packaging (3), Packaging process control (2) and Labeling mix-ups (2).

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

Prosthesis, Hip, Femoral Component, Cemented, Metal

Legion

Reverse T-Handle Chuck

Prosthesis, Hip, Femoral Component, Cemented, Metal

VerSys®

Catalogue number 7833-15, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

‘SL-Plus¿’

SL-Plus MIA Detachable Rasp 10

Prosthesis, Hip, Femoral Component, Cemented, Metal

Centralizer

2 catalogue numbers from 6259-8-120, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Matrix

Matrix Cemented CUP Positioner

Prosthesis, Hip, Femoral Component, Cemented, Metal

Large Cannulated Screws

T-Handle W/Large AO Quick Connect

Prosthesis, Hip, Femoral Component, Cemented, Metal

Plus

Extraction Screw With Lasermarks

Prosthesis, Hip, Femoral Component, Cemented, Metal

Opti-FIX

Optifix Acetabular Drill Guide

Prosthesis, Hip, Femoral Component, Cemented, Metal

Promos

Promos Adapter FOR Slap Hammer

Prosthesis, Hip, Femoral Component, Cemented, Metal

Antholgy

Size 8 Fully Toothed Anthology Broach

Prosthesis, Hip, Femoral Component, Cemented, Metal

Integral Centralizer HIP System

4 catalogue numbers from 11-162717, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Journey

Visionaire EM Alignment Guide

Prosthesis, Hip, Femoral Component, Cemented, Metal

Biomet® Omega 21™ Spinal Fixation System

Catalogue number 129130, listed by Biomet Spine, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Trauma-Shoulders

Bone Graft SAW

Prosthesis, Hip, Femoral Component, Cemented, Metal

Profix

Profix Oxinium Femoral Impactor

Prosthesis, Hip, Femoral Component, Cemented, Metal

Prosthesis Head A

Modular Prosthesis Head,Ceramic - Biolox forte

Prosthesis, Hip, Femoral Component, Cemented, Metal

V40

Catalogue number 6364-2-222, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Distal Centralizer/Centering Sleeve

3 catalogue numbers from 162657, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Imhs

Intramedullary HIP Screw CP Proximal Reamer

Prosthesis, Hip, Femoral Component, Cemented, Metal

Trauma – Misc

205MM Forceps W/ Ball TIP

Prosthesis, Hip, Femoral Component, Cemented, Metal

Hips – Misc

2 catalogue numbers from E0017893-1, listed by Smith & Nephew, Inc., United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

BIO-Moore Endo II HIP System

3 catalogue numbers from 139249, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Instrument

Specialty Exeter Flexible Trial Plug

Prosthesis, Hip, Femoral Component, Cemented, Metal

Redapt

MDF Distal Reamer 240MM Size 10

Prosthesis, Hip, Femoral Component, Cemented, Metal

Platform

Platform HIP Rasp SZ 12

Prosthesis, Hip, Femoral Component, Cemented, Metal

LG Cannulated Screws

Cannulated Reamer 4.8MM W/Hall Jacobs Chuck

Prosthesis, Hip, Femoral Component, Cemented, Metal

Peri-Loc

Reduction Forceps W/Ratchet-Bowed 205MM

Prosthesis, Hip, Femoral Component, Cemented, Metal

Synerygy

Synergy Reamer Short - SZ 8-9-10

Prosthesis, Hip, Femoral Component, Cemented, Metal

RX90 HIP System

7 catalogue numbers from 149029, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Internal Fix

Cable Passer - Large

Prosthesis, Hip, Femoral Component, Cemented, Metal

CHS

Cannulated Plate Tamper FOR Ambi/Classic HIP Screw

Prosthesis, Hip, Femoral Component, Cemented, Metal

Accord

Accord Standard 265MM 11 Cable Trochanteric Grip Trial

Prosthesis, Hip, Femoral Component, Cemented, Metal

Regenerex Ringloc + HIP System

7 catalogue numbers from PT-106060, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

BI-Metric Interlok HIP System

6 catalogue numbers from 12-162301, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Jet-X

JET-X A/O T-Handle Connector W/10MM Socket

Prosthesis, Hip, Femoral Component, Cemented, Metal

Exeter

RimFit Cup

Prosthesis, Hip, Femoral Component, Cemented, Metal

Stanmore™ HIP System

10 catalogue numbers from 164240, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

TaperFit Cemented Hip System

TaperFit Hip Stem 45mm Offset Standard Stem size 4

Prosthesis, Hip, Femoral Component, Cemented, Metal

Spectron

Spectron EF 12/14 Long Straight/Neck Replacement Broach 195MM Medium

Prosthesis, Hip, Femoral Component, Cemented, Metal

Genesis II

Genesis II Posterior Stabilized High Flexion Insert Impactor Head Size 1-2

Prosthesis, Hip, Femoral Component, Cemented, Metal

DJO Surgical

Stem, HIP, FH, 450 Series, SIZE8MM

Prosthesis, Hip, Femoral Component, Cemented, Metal

Sirius

2 catalogue numbers from 31-149135, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Prosthesis Head B

Modular Prosthesis Head,CoCrMo

Prosthesis, Hip, Femoral Component, Cemented, Metal

Polarstem

Polarstem ROD FOR CCD Gauge 100MM

Prosthesis, Hip, Femoral Component, Cemented, Metal

Synergy

Synergy CEM Collared Trial Neck Standard Offset Size 10-11

Prosthesis, Hip, Femoral Component, Cemented, Metal

SMF

SMF Stem Broach Trial Neck Right Anteverted Valgus

Prosthesis, Hip, Femoral Component, Cemented, Metal

RX90 Revision HIP System

16 catalogue numbers from 129126, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Cpcs

Cpcs Trial Neck Size 3H-4H-5H

Prosthesis, Hip, Femoral Component, Cemented, Metal

Corin Taper-Fit Total Hip System

38MM & 45MM Offset Trial Neck (Eurocone)

Prosthesis, Hip, Femoral Component, Cemented, Metal

Tandem

Tandem Straight Threaded Handle

Prosthesis, Hip, Femoral Component, Cemented, Metal

Sirius HIP System

2 catalogue numbers from 51-199337, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Echelon

Echelon Primary Stand Offset Trial Neck Size 13-14

Prosthesis, Hip, Femoral Component, Cemented, Metal

Answer / Impact / Integral HIP System

8 catalogue numbers from 162640, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Trigen

15.5MM Sculptor Pilot Nose Interchange Reamer Head

Prosthesis, Hip, Femoral Component, Cemented, Metal

Biomet® Hip System

4 catalogue numbers from 163660, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

TC-100

Reduction Forceps Angled Pointed-Ball Tips 250MM

Prosthesis, Hip, Femoral Component, Cemented, Metal

Emperion

Emperion Sleeve Trial 11MM MED Cone Slotted Assy

Prosthesis, Hip, Femoral Component, Cemented, Metal

Reflection

Reflection 32MM Inner Diameter 20 Degree +4MM 66-68MM Outer Diameter Trial Liner

Prosthesis, Hip, Femoral Component, Cemented, Metal

Generation 4 HIP System

Catalogue number 165017, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Contour

Contour Reconstruction Ring Trial 56MM Outer Diamter 52MM Inner Diameter Right

Prosthesis, Hip, Femoral Component, Cemented, Metal

Polarcup

Tandem Style Polar CUP Trial Liner 65/28

Prosthesis, Hip, Femoral Component, Cemented, Metal

Answer HIP System

10 catalogue numbers from 162503, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Anthology

Anthology Standard Offset Trial Neck Size 7-12

Prosthesis, Hip, Femoral Component, Cemented, Metal

VLP Foot

Compression Forceps With Screw Holder

Prosthesis, Hip, Femoral Component, Cemented, Metal

Spii Model Lubinus

Hip Prosthesis Stem - XL long neck,Taper 12/14

Prosthesis, Hip, Femoral Component, Cemented, Metal

Renovation

Renovation Thin Osteotome Blade Round END 20MM

Prosthesis, Hip, Femoral Component, Cemented, Metal

Polar

Polar Knock Plate With Threaded Hole

Prosthesis, Hip, Femoral Component, Cemented, Metal

AuRa

6 catalogue numbers from 106-44-23, listed by Exactech, Inc., United States, under Prosthesis, Hip, Femoral Component, Cemented, Metal. 5 manufacturers in China are registered for this product code.

Prosthesis, Hip, Femoral Component, Cemented, Metal

Prosthesis Head Large

Prosthesis Head,

Prosthesis, Hip, Femoral Component, Cemented, Metal

Progeny Hip System

Distal Centralizer, Progeny Cemented Stem, Size 10

Prosthesis, Hip, Femoral Component, Cemented, Metal

R3

R3 20 Degree Permanent Trial Liner 44MM Inner Diameter X 76-80MM Outer Diameter

Prosthesis, Hip, Femoral Component, Cemented, Metal

Prosthesis, Hip, Femoral Component, Cemented, Metal

Ceramic Acetabular Liner Impactor Head 28MM Inner Diameter

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