Broach

Which Manufacturers in China Make This?

6 of the 12 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, Guangdong and Shanghai, and 2 other provinces.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Changzhou Centrau Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
Changzhou Xietong Industries Co., Ltd. Jiangsu
Changzhou Yonghua Medical Instruments Co., Ltd. Jiangsu
Changzhou Master Precision Tool Co., Ltd. Jiangsu, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HTQ?

Broach is FDA product code HTQ, Class 1, 21 CFR 888.4540.

What Does It Take to Sell It in the United States?

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 5 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (2), Process control (1) and Finished device change control (1).

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

Corail

Corail HIP System Corail Revision Broach, Size 14

Polar

Anthology Broach Handle With Offset Adapter

Ascend

Monolithic Broach PIN

UniSyn Hip System

Broach, Standard, Tapered Connector, Size 24/30, Unisyn

Consensus Hip System

Femoral Broach, Cemented, Tapered, 13mm

Integra® Freedom Wrist Arthroplasty System

Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 3

Broach

Tissue Sparing Solutions Anterior Broach Handle Right

OrthoMedFlex

Straight Broach Handle - 135 Degrees

DJO Surgical

SPECIAL, ALTIVATE REVERSE HUMERAL BROACH, 16 X 175mm, MOD.

DJO Surgical

Broach, HUM. Diamondtooth SIZE16 Foundation Shoulder

Medtronic Reusable Instruments

Instrument 3289212 Broach TIP 26MMX12MM

Profemur®

47 catalogue numbers from PRTLSB12, listed by Microport Orthopedics Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Mallory Head

12 catalogue numbers from 31-104516, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Plif

PLIF SG INSTRUMENTS FINISH BROACH, COLOR-CODED 15 x 17mm

C-Stem

C-Stem AMT Broach Size 5

Attune

Attune Knee System Revision Cone X-Large Tibial BI-Lobe Broach Left Medial/Right Lateral

PyroCarbon PIP Total Joint System

PIP. Broach. Proximal. SZ. 20

iNSitu™ Hip System

Hybrid Dual Taper Femoral Broach, Size 22

Integra®

LMP System Proximal Broach, One Size Instrument used to prepareccthe medullary canal of the metatarsal.

Intervertebral Disc Preparation Instruments

LIF, Broach, CC Offset, 14MM X 08MM

Exact Reverse Broach Handle

Catalogue number SSI005620, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Broach

Tissue Sparing Solutions MAKE TO ORDER DUAL OFFSET BROACH HANDLE W SLAP HAMMER INTERFACE RIGHT

Ascension MCP Joint Replacement

MCP Proximal Cutting Broach SZ. 05

Anthology

Anterior Broach SZ 2 Oversized

NuGrip CMC

CMC/THB Broach SZ. 10

Evolve Proline

Proline Stem Broach

Comprehensive® Shoulder System

4 catalogue numbers from 407360, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

BI-Metric Rasp/Provisional

7 catalogue numbers from 31-473614, listed by Biomet UK Ltd., United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

KAR

Catalogue number L95080, listed by Depuy (Ireland), Ireland, under Broach. 12 manufacturers in China are registered for this product code.

Affiniti

Humeral Broach/Trial

Exact/Alliance

11 catalogue numbers from 31-400307, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 00

Catalogue number OSTF-00D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Broach

24 catalogue numbers from 9354-02-355, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Allure Hip Stem

Allure Starter Broach

Calix Spinal Implant System

32mm x 10mm x 11mm PLIF BOX BROACH

General Instrument

LLIF Broach, 8 mm x 18 mm, Flat Top Surface

Endo-Model Knee System – Instruments

Orthopaedic broach - Endo Model Knee System

LinkBio Instrument

Guide Rod, Tibial Cone, D 12/180 L

Link Embrace Shoulder System – Instruments

Orthopaedic broach - LINK Embrace Shoulder System

Alliance®

11 catalogue numbers from 31-473671, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Klassic HD Modular Femoral Broach

Modular Femoral Broach, size 7

BethaLoc®

12 catalogue numbers from 87001060, listed by implantcast GmbH, Germany, under Broach. 12 manufacturers in China are registered for this product code.

Katalyst Bipolar Radial Head System

Broach. 7.5MM X 20MM

Balance Microplasty Broach

28 catalogue numbers from 31-200261, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

StelKast Generic Hip Instruments

ProClass Trial Broach Modified - 12

Tornier Latitude

Humeral Broach Adapter

NuGrip® CMC Implant System

Integra® NuGrip® CMC/THB Broach Sz. 10 The CMC/THB Broach is used to prepare a cavity that provides a press fit for the implant.

Exact™ Alliance® Instruments

23 catalogue numbers from 31-400320, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

TaperSet Hip System

TaperSet, RDP, Broach, 13.5mm

Silicone PIP

Silicone PIP Proximal Broach SZ. 5

Ifuse Implant System-Broach – 7.0mm

Broach - 7.0mm

Spectron

Spectron 12/14 Revision Long Straight/Neck Replacement Broach 165MM Small

Femoral Starter Rasp

Catalogue number 31-555402, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

NexGen®

13 catalogue numbers from 5951-26-07, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Alteon

Alteon Short Tapered Wedge Broach, Chip Breaker Tooth, Size 12

Evolution®

7 catalogue numbers from E2230011, listed by Microport Orthopedics Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Corail

Corail AMT CAS HIP Broach Handle

Neuflex

Neuflex MCP Broach Distal Size 20

Excel

Excel CAS HIP Broach Handle

Trabecular Metal™

5 catalogue numbers from 00-5452-018-30, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

PST LSS Brch Hndle

Catalogue number SSI006885, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

APR®

2 catalogue numbers from 9400-99-201, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 3

Catalogue number OSTF-3D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Shoulder

Cruciate Shoulder Broach SZ 4

Finn®

2 catalogue numbers from 32-471340, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Klassic Blade Femoral Broach

Blade Femoral Broach, size 3

HIP Fracture Stem Broach/Provisional

6 catalogue numbers from 31-473900, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

TRI-Lock

TRI-Lock BPS W/Gription Broach Starter

Summit

Summit Broach Extractor

Broach

DeSoutter Broach Adapter -Anterior Assembly

Omnia Medical PsiF

PsiF Box Cutter Rasp Instrument

EcoFit® Broach for Short Stem 133°

10 catalogue numbers from 70404150, listed by implantcast GmbH, Germany, under Broach. 12 manufacturers in China are registered for this product code.

BioMotion® Cannulated 1st MPJ Hemi System

Integra® BioMotion® Cannulated Hemi System BioMotion Slide Broach The BioMotion Slide Broach is used to prepare a cavity that provides a press fit for the implant.

Battalion

Battalion, Llif Broach, Straight, 18MM X 06MM

Freedom Wrist Arthroplasty System

Radial Broach Size 4 Right

Natural-Knee®

Catalogue number 6290-00-660, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Universal 2™ Total Wrist Implant System

Universal 2™ Total Wrist Implant System RADIAL BROACH EXTRA SMALL RIGHT

Osteotec Silicone Finger – Proximal Rasp Size 2

Catalogue number OSTF-2P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Charnley

Charnley Femoral Broach Roundback Large

Excel TRI-Lock

Excel TRI-Lock Broach Handle Levered

Remotion

Wrist Instr. Radial Broach Left, Large

Alliance Femoral Broach Provisional

5 catalogue numbers from 31-473674, listed by Biomet UK Ltd., United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

IdentiTi

LIF BROACH, STRAIGHT, 18mm X 04mm

Implant Partners™

3 catalogue numbers from K0027301WD, listed by Microport Orthopedics Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

EcoFit® Broach 133°

12 catalogue numbers from 70403150, listed by implantcast GmbH, Germany, under Broach. 12 manufacturers in China are registered for this product code.

Stem Broach 7.5MM

Catalogue number 19460, listed by Biopro, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Aetos Shoulder System

Cruciate Broach Size 3

Exact Straight Trigger

Catalogue number 31-555500, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Bencox DA Instruments Hip System

Starter Rasp

Osteotec Silicone Finger – Proximal Rasp Size 5

Catalogue number OSTF-5P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

General Instruments

Medial/Lateral Angled LIF Broach - 18MMx6MM

Actis

Actis Broach Size 12

Premier-Total™

7 catalogue numbers from 9352-00-006, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Evolve

Modular Radial Head Self Centering Stem Broach

Taperloc Complete Neck Trunnion

Catalogue number 51-201001, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Ifuse Implant System-XL Broach – 7.0mm

XL Broach - 7.0mm

Kgti™ Kinetik Great Toe Implant System

Metatarsal Broach Right Manual

Universal2 Total Wrist Implant System

Broach. X-Small Right

Global Unite

GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY HUMERAL BROACH 6mm

Viant Medical, LLC

Revelation Double Offset Broach Handle

Columbus Revision

Columbus REV Tib.broach/Trial Keel T2/2+

PRO-TOE

VO Broach

Osteotec Silicone Finger – Distal Rasp Size 6

Catalogue number OSTF-6D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

BIO-Modular® / Comprehensive®

Catalogue number 406587, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 7

Catalogue number OSTF-7D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Implafit® Broach

10 catalogue numbers from 80082007, listed by implantcast GmbH, Germany, under Broach. 12 manufacturers in China are registered for this product code.

Silicone Toe System

LMP System Proximal Broach. ONE Size

Global Advantage

Global Advantage + Metal Broach TIP

Mallory/Head Exact PF Broach

2 catalogue numbers from 31-104506, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Synergy

Synergy Select II Reduced Flair Broach Size 10

IdentiTi II

ID II TLIF-A, CURVED BOX CUTTER 10mm

Anthology Afit

ANTHOLOGY AFIT BROACH i SIZE 14

Enduro

Enduro Tibial Broach T2/T3

CS2 Acetabular System/Consensus Hip System

CS2/CHS, Femoral Broach, Press Fit, 20mm

Ascension®

Ascension®MCP, Broach, Proximal, Sz. 50 The Proximal Broach compresses and/or removes cancellous bone to create final cavity of proper shape and size for device press fit.

LCS Completion

LCS Completion REVISION FEMORAL BROACH 40mm

Summit

Summit Make TO Order Lateral Offset ANT Approach Broach Handle Right

Endurance

Endurance Broach Size 3

Global AP

GLOBAL AP HUMERAL STEM BROACH / TRIAL 14mm

Taperloc® Complete

Catalogue number 51-201001, listed by Biomet Orthopedics, United States, under Broach. 12 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