Driver, Prosthesis

Who Makes This Device Type in China?

6 of the 9 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.

B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Jiangsu Kersen Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HWR?

Driver, Prosthesis is FDA product code HWR, Class 1, 21 CFR 888.4540.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 6 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Device Design (2) and Component change control (1).

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

Driver, Prosthesis

ESC Pinnacle

PINNACLE ESC RING INSERTER TIP 32mm

Driver, Prosthesis

MicroFrance®

MicroFrance® Graft remover 4.0mm diam. 100mm length

Driver, Prosthesis

Driver, Prosthesis

Modified Instrument Short Screwdriver, Tapered TIP X15

Driver, Prosthesis

InTess C Cervical Cage System

Implant Inserter, InTess C

Driver, Prosthesis

U2™ Knee

Tibial baseplate driver

Driver, Prosthesis

StelKast Generic Hip Instruments

Stem Inserter, Rotational Control, Provident Anterior Approach

Driver, Prosthesis

Global APG+

Global APG+ Quick Connect Driver Shaft

Driver, Prosthesis

Streamline TL Spinal Fixation System

Strmln TL Yoke Capture RS Setscrew Inrtr

Driver, Prosthesis

Locon-T

Cruciform Driver

Driver, Prosthesis

MicroPort

7 catalogue numbers from 4799SD02, listed by Microport Orthopedics Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Expedium

Expedium Spine System SI SET Screw Inserter FOR Clip-ON Reduction Sleeve 6.35

Driver, Prosthesis

Hex Driver

6 catalogue numbers from 907805, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Offset Femoral Head Impactor

Catalogue number SSI002181, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

OSS Proximal Femoral Inserter

Catalogue number 110024553, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Endoskeleton® TAS

Anterolateral Inserter, Standard Footprint, 10-12mm

Driver, Prosthesis

Viper

Viper 2 System Approximating SET Screw Inserter, Self-Retaining

Driver, Prosthesis

Matrix

Short Click'x Style-Matrix Holding Sleeve/T-Handle Driver

Driver, Prosthesis

Skyline

Skyline Anterior Cervical Plate System Expansion TIP Screwdriver

Driver, Prosthesis

Darco

Hex Headed Driver

Driver, Prosthesis

Phoenix SFS

SET Screw Holder Insert, Short

Driver, Prosthesis

Symphony

Symphony OCT System ROD TO ROD Crossconnector Counter Torque

Driver, Prosthesis

Curved Acetabular Reamer

Catalogue number 31-555522, listed by Biomet UK Ltd., United Kingdom, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Acetabular Shell Inserter

Catalogue number 423609, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

TiWAVE L Lumbar Cage System

Inserter, Offset

Driver, Prosthesis

Moss

MOSS MIAMI MAGNUM SPINE SYSTEM HEX SHAFT 6.35 3.5mm

Driver, Prosthesis

IdentiTi II

Alif SA Angled Screw Removal Driver, 35°

Driver, Prosthesis

Moss

Moss Miami Magnum Spine System Poly Driver Reduction Shaft 6.35

Driver, Prosthesis

AMP-LTX

AMP-LTX Center Screw Driver

Driver, Prosthesis

Maestro(TM) Total Wrist

2 catalogue numbers from 409082, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

HammerTech

HT 2X Driver (2.6mm)

Driver, Prosthesis

Centurion

ROD Connector Torque Limiting Driver

Driver, Prosthesis

Expedium

Expedium Spine System Castle Innie Final Tightener With Torque Indicator

Driver, Prosthesis

Driver, Prosthesis

DePuy MI System ACETABULAR INSERTER REPLACEMENT LOCKING CATCH

Driver, Prosthesis

S-ROM

S-ROM Sleeve Introducer Handle

Driver, Prosthesis

Square Driver

3 catalogue numbers from 8163-01-000, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Affixus®

16 catalogue numbers from 211306004, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Anthology

Posterior Approach Stem Pusher

Driver, Prosthesis

ACE

infinity TRICAM 6POINT RATCHET SPLINE DRIVER 21.8MM LONG SS 17-4 (H900)

Driver, Prosthesis

Repicci II Knee Femoral

Catalogue number 32-454930, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Trialtis

TRIALTIS Spine System Set Screw Inserter,T27 Extra Long

Driver, Prosthesis

G-Force

Tenodesis System Hex Driver

Driver, Prosthesis

In2Bones

Lag Screw Driver, T15, Cannulated, Sterile, Single-Use

Driver, Prosthesis

Dart-Fire

Star 15 Driver

Driver, Prosthesis

Driver, Prosthesis

DePuy MI System ACETABULAR INSERTER REPLACEMENT BUTTON

Driver, Prosthesis

Natural-Knee®

Catalogue number 6290-00-716, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

77MM Bridgeback RMR

Catalogue number SSI006838, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

SkyOPS

Inserter, Medial Bunion-Alt Distal (Right)

Driver, Prosthesis

InnoOrtho

11 catalogue numbers from WIOR Handle, listed by Innoortho Co., Ltd., South Korea, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Wright

Catalogue number DSDS0160, listed by Wright Medical Technology, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Frontier

Frontier Anterior Deformity System CAP Inserter

Driver, Prosthesis

Inhance

Inhance Shoulder System ONE Step Prep Glenoid Reamer – Circular X-Large

Driver, Prosthesis

Timx

Timx LOW Back System Hexlobe Driver

Driver, Prosthesis

Mountaineer

Mountaineer OCT Spinal System OC Univ. Joint Torque Driver

Driver, Prosthesis

Evolve

Cruciform Driver, Radial Head Plate

Driver, Prosthesis

Uniplate

Uniplate Anterior Cervical Plate System Standard Driver

Driver, Prosthesis

X-Mesh

X-Mesh Expandable Cage System Posterior Inserter Superior Straight TIP-Medium

Driver, Prosthesis

Isola

ISOLA SPINE SYSTEM LOW PROFILE HOOK DRIVER 4.75mm

Driver, Prosthesis

Acumed

T10 Cannulated Stick Fit Hexalobe Driver

Driver, Prosthesis

Ocata Anterior Cervical System

Driver Shaft, Final Tighten

Driver, Prosthesis

Trigen

Modified Medium Hexdriver

Driver, Prosthesis

Elemax® Cortical Cancellous Spacer

Inserter Shaft with Stop

Driver, Prosthesis

Summit

Summit Make TO Order 30-DEG Stem Inserter

Driver, Prosthesis

Summit

SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER ASSEMBLY, IN-LINE 2.5mm

Driver, Prosthesis

Charnley

Charnley Cement Restrictor Introducer Modified

Driver, Prosthesis

Driver, Prosthesis

Driver Star 10 Self Retaining

Driver, Prosthesis

Reclaim

Reclaim Monobloc – Revision HIP System Stem Inserter Locator

Driver, Prosthesis

Driver, Prosthesis

MTO Retrograde Reamer Locking Shaft

Driver, Prosthesis

CosmoLock Pedicle Screw System

Driver Shaft, T15, Cross Link Final Driver

Driver, Prosthesis

Delta Xtend

DELTA Xtend HUMERAL IMPLANT DRIVER

Driver, Prosthesis

Mountaineer

Mountaineer OCT Spinal System Hook Inserter

Driver, Prosthesis

Mica

2 catalogue numbers from 57S02020, listed by Wright Medical Technology, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Endoskeleton® TL

Angled, Standard Inserter, 22mm

Driver, Prosthesis

Invictus

Inserter - Variable Cross Connector

Driver, Prosthesis

Mobio™ Specialty

Catalogue number 8829P03028, listed by B-ONE Ortho, Corp., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Centraloc(TM)

Catalogue number 905685, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Bengal

Bengal Stackable Cage System Distractor PIN Driver

Driver, Prosthesis

54MM Bridgeback RMR

Catalogue number SSI006815, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

48MM Bridgeback RMR

Catalogue number SSI006809, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

SFS

Lateral Hook Holder, Straight SFS Hook System

Driver, Prosthesis

Revision Knee System

RKS, Peg Driver, .25 Hex

Driver, Prosthesis

Indy Standalone

Side Handle, Angled Geared Driver

Driver, Prosthesis

Ortholoc

Driver Star 10

Driver, Prosthesis

Ascent LE

Torque Limiting Driver, Ascent LE Poct

Driver, Prosthesis

Viper

Viper System LAG Screw Quick Connect Driver 5.5

Driver, Prosthesis

Cannulated Screw System

Screw Cruciate Driver

Driver, Prosthesis

Firebird SFS

SET Screw Holder / Driver, Modular, Short

Driver, Prosthesis

Driver, Prosthesis

22 catalogue numbers from 9375-00-051, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Pathway

Pathway PIN Inserter

Driver, Prosthesis

Square Driver – MQC END

Catalogue number 231200102, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

59MM Bridgeback RMR

Catalogue number SSI006820, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Plif

PLIF SG INSTRUMENTS CAGE INSERTER TIP ASSEMBLY 11mm

Driver, Prosthesis

General Instruments

Tulip Head Turner - Extra long, large diameter, shortened tip

Driver, Prosthesis

Titan Inserter

Inserter X0420002 Endo TO Inserter

Driver, Prosthesis

Arthrex®

Mini-Rail Patient Clamp Driver - Single

Driver, Prosthesis

Ascent

Torque Limiting Driver, T-Handle, Ascent LE/Ascent Poct

Driver, Prosthesis

Leopard

Leopard System Quick-Release Inserter

Driver, Prosthesis

U2 Total Knee System

Patellar capture, asymmetric onset, NON-CEM, XXL, Ø41mm

Driver, Prosthesis

ComposiTCP™

Catalogue number 905278, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

70MM Bridgeback RMR

Catalogue number SSI006831, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

TCP

3 catalogue numbers from 08-601, listed by Wright Medical Technology, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

LAG Screw Driver

Catalogue number 8215-10-000, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

T-15 Tapered Driver Short

2 catalogue numbers from 2312-18-021, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Global CAP

GLOBAL CAP HUMERAL HEAD SHAPER 52mm x 21mm

Driver, Prosthesis

Arsenal

Polyaxial Provisional Locking Tool

Driver, Prosthesis

Cable-Ready®

2 catalogue numbers from 2232-50-05, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

49MM Bridgeback RMR

Catalogue number SSI006810, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

FuzeFix Large

Driver Torx FT 5.5mm

Driver, Prosthesis

Excel

Excel Short Driver

Driver, Prosthesis

Cougar

Cougar LS Lateral Interbody Instrument System Insertion Shim - Right Blade

Driver, Prosthesis

Eagle Swift

Eagle/Swift Anterior Cervical Plate System Holder, Straight

Driver, Prosthesis

Mobio™ Total Knee System

2 catalogue numbers from 8829011000, listed by B-ONE Ortho, Corp., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Driver, Prosthesis

Liner Inserter Handle - Straight Assembly

Driver, Prosthesis

Compress(R) Instrument

Catalogue number 32-481007, listed by Biomet Orthopedics, United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

MP Monoblock – Instruments

2 catalogue numbers from 136-202/03, listed by Waldemar Link GmbH & Co. KG, Germany, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Glenosphere Forceps

Catalogue number SSI006680, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

41MM Bridgeback RMR

Catalogue number SSI006802, listed by Zimmer, Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

Driver, Prosthesis

Cetra

Double Driver

Driver, Prosthesis

Ti6® Internal Fixation System

Integra® Ti6® The Ti6 Base Instrument Set contains instruments used to aid in the implantation of the Ti6 Screws.

Driver, Prosthesis

InTess Lumbar Cage

Implant Inserter, 11-13mm, Sleeveless

Driver, Prosthesis

Advantim®

2 catalogue numbers from 18710180, listed by Microport Orthopedics Inc., United States, under Driver, Prosthesis. 9 manufacturers in China are registered for this product code.

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