Impactor

Who Makes This Device Type in China?

18 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shanghai and Beijing, and 3 other provinces. 7 of them are contract manufacturers, able to build to a buyer’s own specification.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Beijing Rossumrobot Technology Co., Ltd. Beijing
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
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
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Reach Medical Instrument Co., Ltd. Shanghai
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

What Is FDA Product Code HWA?

Impactor is FDA product code HWA, 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 Do the Recalls Say?

The FDA has recorded 27 recalls under this product code since 2003. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (10), Process design (3) and Nonconforming Material/Component (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

HP Femoral Impactor / Extractor

Catalogue number 950501220, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

LPT

Great Toe, Straight Impactor

Silex Sacroiliac Joint Fusion System

Custom Impaction Driver

Large UNI-Clip®

The impactor tip is assembled with the impactor handle with reference 119319ND. The side of the impactor to be used is determined by the staple size.

IdentiTi

IdentiTi ALIF SA, Impact Cap

CUP Pusher Head

Catalogue number SSI005704, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor for Humeral Stem

Catalogue number 72.01.00-01, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor Shaft

Catalogue number 324-0022, listed by OsteoCentric Technologies,Inc, United States, under Impactor. 18 manufacturers in China are registered for this product code.

VG2

VG2 Cervical Instruments Impactor

Enztec Femoral Head Pusher Head – Size 40

Catalogue number 4250-2140, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Plif

Plif Impactor-Short

T-Handle, Impactable, S-Couple

Catalogue number 8210-69-000, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Impactor Interface Sz 43

Catalogue number 351342512143, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 3/8-16 UNC-03

Catalogue number 4252-2369, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Impactor Interface Sz 57

Catalogue number 351342512157, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Manipulation Handle

Catalogue number 351342512003, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Phalinx

Hammertoe Implant Impactor

Domed Femur/Tibia Impactor Head

Catalogue number 2115.00.100, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – DJO

Catalogue number 800-05-035, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Phantom® Fibula Nail System

Impaction Attachment

NuGrip CMC

Basal Thumb Impactor

OCI Trinket X 5/16-24 UNF-01

Catalogue number 4252-2335, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Premium OCI – 3/8-32 UNEF-01

Catalogue number 4252-2110, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Specialist

Specialist 2 Tibial Tray Impactor Nylon - Replacement

Tibial Broach Impactor, Revision

Catalogue number 2904.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Femoral Stem Impactor With Anteversion

Catalogue number 1307.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Polarstem

Polarstem Ball Head Impactor

OSS/Mosaic

Catalogue number 405056, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

TJO – Tibial Impactor Head

Catalogue number 2227.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Freedom

Catalogue number 31-107037, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 3/8-24 UNF-01

Catalogue number 4252-2361, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Alamo P, Alamo T

Impactor Instrument, Straight

Klassic Blade Femoral Stem Impactor, Angled Tip

Blade Femoral Stem Impactor, Angled Tip

Shell Impactor

Catalogue number 02820030, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Instruments

Restoration Modular Inst Syst Conical Distal Stem Trial Impactor

Helianthe

Catalogue number APA10330, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI

Catalogue number 4252-2060, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Pit’stop®

Pit'stop External Holder

Cap Impactor

Catalogue number 78010002, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor Head

Catalogue number 4240-3061, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor – 3/8-28 Interface

Catalogue number AAZ009-000, listed by Incipio Devices, United States, under Impactor. 18 manufacturers in China are registered for this product code.

GluOn-IF

Catalogue number GS136-2110, listed by GS Medical Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Tibial Insert Impactor

Catalogue number 9403-5103, listed by United Orthopedic Corp., Taiwan, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – Microport

Catalogue number 4240-3083, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

DePuy MI System ACETABULAR INSERTER REPLACEMENT SPRINGS

Casper Bone Impactor 4mm

A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt…

Femoral Impactor

Catalogue number 110004685, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Vantage

Ankle Impactor Handle

Universal2 Total Wrist Implant System

Carpal Poly Impactor

BMP Cable Grip Impactor

Catalogue number 498006, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Consensus Knee System/Revision Knee System

Impactor, Tibial/Femoral, All Plastic, Large, Large Handle

Axle Interspinous Fusion System

IMPLANT INSERTER TIP, 42 x 30mm

Femoral Impactor Extractor Head

Catalogue number 261-0001-01, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Dr.Paleys Osteotomy System

Dr PALEY OSTEOTOME LEVER

Vu e-POD

Secondary Impactor Assembly

OCI Trinket X M8x1.25-01

Catalogue number 4252-2331, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Modular Impactor Handle

Catalogue number 2125.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

United Orthopedic Femoral Driver Head

Catalogue number 9303-5711, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI XR

Catalogue number 4252-2420, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Acetabular Liner Impactor Adapter

Catalogue number PPENZLMA, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Cup Impactor Curved Constrained

Catalogue number 29500606, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Vanguard(TM) Premier Instruments

Catalogue number 32-486211, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Titan Modular Shoulder System

TSS Head Impactor

Polaris 5.5 Spinal Fixation System

5.5 Hook Impactor

Accessory Conn. M8

Catalogue number H0034000309, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Global APG+

Global APG+ Glenoid Impactor TIP

OCI Trinket X 3/8-16 UNC-02

Catalogue number 4252-2338, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Alternate Bearing

Catalogue number 31-131004, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Discovery Elbow Humeral Impactor

Catalogue number 414924, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

MDI

Catalogue number 74001014, listed by Wright Medical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Inhance Intact

Inhance Intact Impactor Handle Adapter

M2A-38MM CUP Impactor Sleeve

Catalogue number 31-103612, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Tasmin R

Catalogue number Graft loading platform, listed by Signus Medizintechnik Gmbh, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Positioning Handle – 3/8-16 Interface

Positioning handle assembly accessory for offset cup impactor 3/8-16 interface

Universal Cone Impactor Head, Size 4, 18°

Cone Impactor Head, Size 4, 18 degrees

Ascension MCP Joint Replacement

MCP. Impactor. Proximal

Oxford Partial Knee SystemFemoral Impactor

Catalogue number 32-420127, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

S-ROM

S-ROM Head Impactor

Universa Cone Impactor Head, Size 2, 12°

Cone Impactor Head, Size 2, 12 degrees

Modular Knee Impactor Head, Femur

Catalogue number 2130.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Devex

Devex System Straight Impactor

Sampedro

Bone Impactor 6mm

S-ROM Noiles

S-ROM Noiles Impaction Base

Xsert Lumbar Expandable Interbody System

Catalogue number T092-0100, listed by Xtant Medical Holdings, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Acetabular Offset Handle

Catalogue number PPENZOFF, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

MD Vue Lateral Access

Shim Inserter / Impactor

Forefoot Solutions™

The staple impactor is used to impact the staples to ensure that thay are flush with the bone surface.

Polarcup Impactor Interface Sz 49

Catalogue number 351342512149, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Veptr II

Angled Lock Impactor Veptr II

LCS

LCS High Performance Femoral Notch Impactor

Tornier Simpliciti

Humeral Head Impactor Tip

Inhance Shoulder System

Inhance Shoulder System Ready-SET GO General KIT NA NA

G7 Curved Acetabular Shell Inserter Round TIP

Catalogue number 110010765, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Global Icon

GLOBAL ICON Stemless Shoulder System HUMERAL HEAD IMPACTOR TIP

Enztec Femoral Impactor Head – Corin

Catalogue number 1231148, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

P.F.C.

P.F.C. Femoral Head Impactor

Active Articulation™ Hip System

Catalogue number 31-139270, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Standard Plate Impactor Head

Catalogue number 14581, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Tornier HRS Max

Inserter & Extractor Handle

Captured HIP Screw Impactor Head

Catalogue number 14580, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

BIO-Moore II Stem Inserter

Catalogue number 31-482465, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Sigma LCS

Sigma High Performance LCS High Performance MBT Keel Punch Impact

Noval

Catalogue number Graft loading platform, listed by Signus Medizintechnik Gmbh, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Aequalis Resurfacing Head

Cannulated Impactor TIP

Resolve Modular Revision Stem

Proximal component impactor

BIO-Moore II

Catalogue number 31-482490, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Acetabular RIM Punch

Catalogue number 423611, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M8x1.25-02

Catalogue number 4252-2371, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Head Pusher Head – Size 32

Catalogue number 4250-2132, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Tahoe Unicompartmental Knee System

TUKS, Tibial Insert/Femoral Impactor, All Plastic

Femoral Impactor Extractor

Catalogue number 261-0001, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

b-ONE Hip Instrumentation

Straight Stem Impactor, Non-Modular

Modular Hip Impactor Head, Femoral Head

Catalogue number 1342.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Salto Talaris Total Ankle Prosthesis

Salto Talaris. Tibial Impactor

U-Motion Acetabular Component

Catalogue number 9204-1222-RB, listed by United Orthopedic Corp., Taiwan, under Impactor. 18 manufacturers in China are registered for this product code.

Liner Impactor Plate Head

Catalogue number 423622, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

OCI X T-Handle Driver

Catalogue number 4252-2314, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

OCI Trinket X 7/16-20 UNF-02

Catalogue number 4252-2339, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

First Choice® Druj System

Integra® First Choice® DRUJ System MUH Stem Impactor The Modular Ulnar Head stem impactor impacts the stem into selected head placed in the back table assembly.

Integra® Jarit®

Integra® Jarit® Bone Graft Impactor, 8-3/4", Double-Ended, 11mm-14mm 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