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.

Prostep™ TBI

Broach Set

Movement Great Toe System

Proximal Phalanx Broach

Ultimate-C

Ultimate-C Broach Handle

Gsource

Viper gBroach, Box Cutter, 13 1/2" with Silicone Handle, Black

Uhead

Ulnar Broach Assembly; Size 1

Mallory-Head® Exact™

Catalogue number 31-104519, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Exact™

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

Osteotec Silicone Finger – Proximal Rasp Size 3

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

Titan Humeral Resrfacing Arthroplasty System

HRA Starter Broach

Lospa Modular Knee System

Tibial Offset Broach

Discovery Elbow

Catalogue number 414931, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Global CAP

Global CAP Implant Stem Punch

Swanson

Intramedulary Broach

Ifuse Implant System-Broach – 10.75mm

Broach - 10.75mm

Osteotec Silicone Finger – Distal Rasp Size 2

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

Avenir PST LSS Brch Hndl

Catalogue number SSI007099, listed by Zimmer, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Broach

Catalogue number 02-00179, listed by Treace Medical Concepts, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 1

Catalogue number OSTF-1D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

LPT

Great Toe, Broach

Oracle

Oracle Broach

Katalyst™ Bipolar Radial Head System

7.5MM Broach Long

P.F.C.

P.F.C. Broach Handle Alignment ROD

Tibial Broach Stem

Tibial Broach Stem, 150mm

Humelock II Cemented Shoulder System

K-WIRE Ø2.0mm L.180mm

Ifuse Implant System-Broach – 4.0mm

Broach - 7.0mm

LMH

Catalogue number 62001001, listed by Wright Medical Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Modular Tibial Broach, Klassic ONE

Modular Tibial Broach, Sz 5-6

Titan

Catalogue number L44519, listed by Depuy (Ireland), Ireland, under Broach. 12 manufacturers in China are registered for this product code.

AML Excel

AML Excel Broach Handle

MDI

2 catalogue numbers from 74000034, listed by Wright Medical Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 4

Catalogue number OSTF-4D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Catalystem

Catalystem Starter Broach

DigiFuse Cannulated Intramedullary Fusion

Digifuse Broach

Osteotec Silicone Finger – Distal Rasp Size 0

Catalogue number OSTF-0D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Elite

Elite IN-Line Broach Handle

Ifuse Implant System-XL Broach – 4.0mm

XL Broach - 4.0mm

Finn Sleeve Augment

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

Osteotec Silicone Finger – Proximal Rasp Size 7

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

Global

Global Original Broach Handle

Stem Broach 8.5MM

Catalogue number 19461, listed by Biopro, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

UNI-Elbow

Radio Capitellum, Broach Right, LG

MIB Broach

Catalogue number 317-00-006, listed by Trilliant Surgical LLC, United States, under Broach. 12 manufacturers in China are registered for this product code.

Rhead

Radial Broach Assy; Size 4

Osteotec Silicone Finger – Distal Rasp Size 9

Catalogue number OSTF-9D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 5

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

Osteotec Silicone Finger – Proximal Rasp Size 00

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

Osteotec Silicone Finger – Proximal Rasp Size 9

Catalogue number OSTF-9P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Distal Rasp Size 8

Catalogue number OSTF-8D, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Anterior Starter Broach

Catalogue number 1115.00.000, listed by Total Joint Orthopedics, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Modular Radial Head (MRH) System

Radial Head Broach Size 24

Integral Femoral Rasp

Catalogue number 31-473618, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Keel Lock Implant System

Keel-Lock Broach Assembly

Alliance Femoral Broach/Provisional

Catalogue number 31-473675, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

OSS™

5 catalogue numbers from 110018801, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Incompass Total Ankle System

Broach Tibial Peg

Titan Humeral Resurfacing Arthroplasty

Humoral Broach SZ. 2

All-Poly Tibial Broach, Klassic ONE

All-Poly Tibial Broach, Size 3-4

SkyOPS

Broach, Hallux Limitus/Dorsal Bunion

Inhance Shoulder System

Inhance Shoulder System Humeral Prep KIT Extra Large NA

Shark Tooth Taperloc Rasp/Prov

Catalogue number SSI001794, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Legion

Long Femoral Cone Broach - 20MM R

Micronail

5 catalogue numbers from 26949451, listed by Wright Medical Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Proximal Rasp Size 6

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

DigiFuse® Cannulated Intramedullary Fusion System

Integra® DigiFuse® DigiFuse Broach The DigiFuse Broach is used to prepare a cavity that provides a press fit for the implant.

Osteotec Silicone Finger – Proximal Rasp Size 8

Catalogue number OSTF-8P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Proximal Rasp Size 0

Catalogue number OSTF-0P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

BioMotion Cannulated 1st MPJ Hemi System

Biomotion Slide Broach

Broach

Modified Instrument Cannulated Reamer

Osteotec Silicone Finger – Proximal Rasp Size 1

Catalogue number OSTF-1P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Stem Broach 10.0MM

Catalogue number 19462, listed by Biopro, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

PROstep™ TBC

6 catalogue numbers from 97700013, listed by Wright Medical Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Osteotec Silicone Finger – Proximal Rasp Size 4

Catalogue number OSTF-4P, listed by Osteotec Limited, United Kingdom, under Broach. 12 manufacturers in China are registered for this product code.

Made-To-Order

Infinity Extended Peg Broach

MaxLock

MINI EdgeLock™ BROACH

Stem Broach 11.5MM

Catalogue number 19463, listed by Biopro, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

All-Poly Tibial Broach Tower Assembly

All-Poly Tibial Broach Tower Assembly, Sizes 3-4

3s Hemi

3S Hemi L/XL Broach, Non-Sterile

Broach

Broach FOR TI Femoral Nails

TheRay Collared and Collarless Femoral Stem

Femoral Broach, Collared Stem, Size 10

OSS Femoral Augment Broach

5 catalogue numbers from 110018805, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Delta Xtend

DELTA Xtend PLATE FOR BROACH HANDLE

OrthoMedFlex, LLC

Dual Offset Broach Handle, Right for RH user

Aequalis Reversed II

Cylindrical Rasp

S-ROM

S-ROM MI BROACH 19 x 24

Maestro(TM) Total Wrist

3 catalogue numbers from 409072, listed by Biomet Orthopedics, United States, under Broach. 12 manufacturers in China are registered for this product code.

Revision Modular Tibial Broach

Revision Modular Tibial Broach, Sz 5

Movement®

Movement® Great Toe System Proximal Phalanx Broach The Movement Great Toe Proximal Phalanx Broach is used to prepare a cavity that provides a press fit for the implant.

Silicone PIP

Broach, Proximal, Size 10

Premia

Catalogue number L95078, listed by Depuy (Ireland), Ireland, under Broach. 12 manufacturers in China are registered for this product code.

Advance®

6 catalogue numbers from K0027301, listed by Microport Orthopedics Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Charnley Elite

Charnley / Elite Broach FL45 EH

Femoral Broach

Femoral Broach, Size 7

Infinity

Tibial Peg Broach, Posterior

Silicone MCP

Metacarpal Broach, Size 00

Endo-Fuse

2 catalogue numbers from 500026, listed by Wright Medical Technology, Inc., United States, under Broach. 12 manufacturers in China are registered for this product code.

Expedium

Expedium Spine System Head Broach/Reamer

Tibial Broach

Tibial Broach, Size 1-2

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