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.

Vanguard M Unicompartmental Knee

Catalogue number US32-421041, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

Intermediate VHS Impactor TIP

Catalogue number 35-463238, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

TaperSet Hip System

TaperSet, Assembly, Stem Impactor, Offset, Non-Threaded

Microplasty Instruments

Catalogue number 31-555523, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

Prospace

Prospace Peek Impactor

Charnley Femoral Prosthesis Pusher

Catalogue number PN2670, listed by Platts & Nisbett Limited, under Impactor. 18 manufacturers in China are registered for this product code.

Affixus®

Catalogue number 211304006, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

DJO Femoral Impactor Head

Catalogue number 800-05-036, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Positioning Handle – M8x1 Interface

Positioning handle assembly accessory for offset cup impactor M8x1 interface

K2™ Hemi Toe Implant System

K2 Hemi Impactor

CUP Impactor 4.0 M8x1

Catalogue number H0034300099, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

OSS

Catalogue number SSI000150, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

LinkSymphoKnee – Instruments

4 catalogue numbers from 881-041/99, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Impactor Interface Sz 51

Catalogue number 351342512151, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket 3/8-16 UNC-01

Catalogue number 4252-2352, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Glenosphere Impactor

Catalogue number 78010006, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

AnyPlus®

2 catalogue numbers from GS136-1460, listed by GS Medical Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Cable-Ready®

Catalogue number 2232-11, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Genesis II

Genesis II Tibial Tray Implant Impactor W Alignment

Pin Inserter

Catalogue number 42230006, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Coral

Fixed Cross Connector Impactor

LCU Hip System – Instruments

2 catalogue numbers from 130-622/01, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Univation XF

Univation XF Tibial Impactor

MBT Tibial Impactor Replacement Parts

Catalogue number 950501559, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M8x1.00-04

Catalogue number 4252-2374, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

VHS Plate Impactor

Catalogue number 35-463110, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

3 catalogue numbers from ODIU03, listed by Orthopedic Designs North America, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor – AR Nose-90°

Nose accessory for offset cup impactor with anti-rotation feature

Inbone

Poly Impact Tool

Biofoam

Catalogue number 46640001, listed by Wright Medical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Offset Cup Impactor – M8x1 Interface

3 catalogue numbers from 01.15.10.0556, listed by Incipio Devices, United States, under Impactor. 18 manufacturers in China are registered for this product code.

P.F.C.

P.F.C. Stem Impactor

Global Unite

Global Unite Anatomic Implant Holder

FRA

Small Stature FRA Impactor

Synergy

Synergy Offset Stem Impactor

Impactor

Offset Tibial Impactor/Slap Hammer

OCI Trinket X M8X0.75-01

Catalogue number 4252-2340, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Lospa IS Spinal System

Plif Final Impactor

Persona Tibial Offset Impactor

Catalogue number SSI006275, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Discovery(TM) Elbow Instruments

Catalogue number 414927, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Endoskeleton® TL

Catalogue number 7200-1011, listed by Medtronic Sofamor Danek, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Journey II UK

Lateral Tibia Impactor

Accessory Tracker

Catalogue number H0034000499, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Extractor

Catalogue number ODIF06, listed by Orthopedic Designs North America, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Quantum

QUANTUM Impactor Tip Tibial Implant

Evolve

Stem Impactor Adapter

3s Hemi

3S Hemi Impactor Head, Non-Sterile

Impactor TIP Flat

Catalogue number 18284, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

OCI Hex Driver+

Catalogue number 4252-2301, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Cone Impactor Head

Cone Impactor Head, Size 1-2, 12°

CUP Impactor M10

5 catalogue numbers from H0031000099, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Head Pusher Head – Size 28

Catalogue number 4250-2128, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI – Trinket 5/16-24 UNF-02

Catalogue number 4252-2095, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

UTF Hip Stem

Curved stem impactor

Vanguard®

Catalogue number 32-486213, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI X

Catalogue number 4252-2310, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

OCI Trinket X 3/8-16 UNC-01

Catalogue number 4252-2332, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Classic OCI – Trinket 7/16-20 UNF-01

Catalogue number 4252-2092, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Tools – FMS

5th Met Hook Plate Impactor

Polarcup Impactor Interface Sz 67

Catalogue number 351342512167, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Calix Lumbar Spinal Implant System

Assembly, Special Inserter

StelKast Generic Hip Instruments

Head Impactor Handle and End Assembly

Cup Locator Rod

Catalogue number 9201-1101-RE, listed by United Orthopedic Corp., Taiwan, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec XR Trinket 7/16-20 UNF-01

Catalogue number 4252-2446, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Head Pusher – Handle

Catalogue number 4250-2100, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Positioner Handle

Catalogue number SSI005861, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Vital Spinal Fixation System

Posterior Wall Impactor 29 mm

Compress® Instrument

Catalogue number 32-481029, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Pin Impactor

Catalogue number 77000108, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Endo-Fuse

2 catalogue numbers from 500034, listed by Wright Medical Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Generic Instruments

Sled Impactor

Anthology

Extended Femoral Head Impactor

Universal Acetabular Impactor Handle

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

OsteoBridge™

OsteoBridge IKA Knee Arthrodesis Impactor non-sterile

Specialist

Specialist 2 Polyethylene Tibial Component Impactor

LP Ring LOC Acetabular CUP

4 catalogue numbers from 423678, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

LCS Completion

LCS Completion REV FEMORAL IMPACTOR SHAFT

Comprehensive SRS Instrument

3 catalogue numbers from 405167, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Trinket M8X1.00-02

Catalogue number 4252-2366, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Staple Tamp

Catalogue number 510-00-005, listed by Trilliant Surgical LLC, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Surgical Instrument

2 catalogue numbers from 111-297, listed by Jeil Medical Corporation, South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Premium OCI – 3/8-16 UNC-01

Catalogue number 4252-2010, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Harmony

Modular Universal Tibial Impactor

Accessory Screwdriver

Catalogue number H0031600399, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Stability

Sigmoid Notch Impactor Tool, SM

Hintermann Series

Hintermann Series Tibial Impactor - Straight

Invictus

3 catalogue numbers from 16092, listed by Alphatec Spine, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Global AP

Global AP Impact Block Assembly

Enztec XR Trinket 5/16-24 UNF-01

Catalogue number 4252-2441, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Identity™

Catalogue number SBHH3300, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

OSS Augment Impactor

Catalogue number 110018814, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

MP Reconstruction System – Instruments

Catalogue number 131-379/00, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Cone Impactor Head, Size 7, 24°

Cone Impactor Head, Size 7, 24 degrees

Versys

3 catalogue numbers from SSI004911, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Pilling

4 catalogue numbers from IPN020037, listed by Teleflex Medical LLC, United States, under Impactor. 18 manufacturers in China are registered for this product code.

NON-Modular Impactor Handle

Catalogue number 32-468430, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Pusher 3 LEG 10×8

Catalogue number 18311, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Cage Impact Curved

Catalogue number 72741-37001, listed by Hankil Tech Medical Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Newclip Instruments

2 catalogue numbers from ANC1146, listed by Newclip Technics SAS, France, under Impactor. 18 manufacturers in China are registered for this product code.

Endoskeleton® TT

Thin Implant Pusher

Offset Cup Impactor – M8x0.75 Interface

2 catalogue numbers from 50341402, listed by Incipio Devices, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Lumbar/Cervical Impactor

Lumbar/Cervical Impactor Micro Lateral Offset Without Heel

TJO – Femur Impactor Head

Catalogue number 2130.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

TC-100

Cannulate Blade Plate Impactor Small

Kincise

Kincise Make TO Order V2 Emphasys Straight Shell/Liner Impactor Short

Tornier Latitude

Radial Head/Stem Impactor

Link Instruments – Forceps and Clamps

3 catalogue numbers from 317-722, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Femoral Impactor – TJO

Catalogue number 2109.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Compress(R)

Catalogue number 32-481029, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Precice® Trauma Nail System

Short Impactor

StelKast Generic Knee Instruments

2 in 1 Impactor, Centering, Large

3.8 CS Strike Pin

Catalogue number 6117-00, listed by Interventional Spine, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Stainless Steel

Rod Guided Hook Impactor

Surgical Instruments

Implant Impactor

Humelock Reversed Shoulder

Humelock Reversed Handle CUP Impactor

ACF

Impactor FOR ACF Allograft Spacers

Vanguard Control Impactor

Catalogue number 32-486213, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Polarcup Impactor Interface Sz 47

Catalogue number 351342512147, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Intuition

Intuition FOR HP Partial Femoral Impactor

Klassic Blade Femoral Stem Impactor, Ball Tip

Blade Femoral Stem Impactor, Ball Tip

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