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.

Impactor

Surgical Titanium Mesh Impactor, Mini Straight

R3

R3 Anti-Rotation TIP W/Flat SZ66/70MM

Enztec Straight Cup Impactor – Corin

Catalogue number 4252-2401, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

DJO Surgical

EMP Rev Knee, Symmetric Cone, Impactor Head, Femoral, LG

Irix-A Lumbar Integrated Fusion System

Universal Joint Guided HEX Driver, Assembly

MicroPort

17 catalogue numbers from APA07062, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Femur/Tibia Implant Impactor Handle

Catalogue number 2110.00.000, listed by Total Joint Orthopedics, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Viant Medical, LLC

Metal Handle Offset Cup Impactor

Advance

21 catalogue numbers from 16100163, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

U-Motion II

Final cup impactor, large

Made-To-Order

Inserter Adjustable Revers

Ringloc® Instrumentation

5 catalogue numbers from 31-111140, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

M2A Acetabular Face Impactor

12 catalogue numbers from 31-177858, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

10.0MM X 20MM Cancellous Bone Impactor-Rectangular

OSS™ Orthopedic Salvage System

4 catalogue numbers from 110029077, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Apex 3d S Total Ankle Replacement System

Short Stem Tibia, Instrument, Graft impactor - D10.5

Attune

Attune Knee System Revision Cone Large / X-Large Concentric Impactor

Gender Solutions®

Catalogue number 00-5927-080-00, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Gsource

gGraft Holder/Impactor Fcps, Bone 10" serr, 6.4mm cross serrated end

Innomed, Inc.

11mm x 4mm Impactor Tip Rectangular Steel

Vanguard 360

Catalogue number 32-422925, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Mosaic™

2 catalogue numbers from 405052, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Freedom® Instruments

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

Kmedic

Bone Chip Packer 10" 6 Millimeter X 19 Millimeter

Duraloc

DURALOC MAKE TO ORDER Cup Impactor with Strike Plate Shaft 13 IN

Gold Ring Retainer

16 catalogue numbers from 110005130, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Titan Modular Shoulder System 2.5

TSS PEG Cement Pressurizer. 2.5 XS/S

Enztec Femoral Impactor With Slap Hammer – Corentec

Catalogue number 4240-3102, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

Impactor X0315106 Posterior Body Wide 20

Humelock II Cemented Shoulder System

Humelock Anchoring Plate Impactor Handle

Ringloc + Instrumentation

9 catalogue numbers from 31-400627, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

Arsenal Ankle

Arsenal Ankle Hook Plate Tamp

U-Motion™

Ceramic head impactor, 28mm

Concorde

Concorde LS Lateral Cage System Impactor

Alteon

Cup Impactor Handle Extension

Apex Knee System

Knee Femoral Impactor Pad with Center Boss, Sz 4-6

Active Articulation Head Impactor Adaptor

Catalogue number 110024743, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

CUP Impactor M8x1

5 catalogue numbers from 01.15.10.0636, listed by HPF SRL, under Impactor. 18 manufacturers in China are registered for this product code.

Novo Surgical Inc.

cloward style graft impactor, double-ended, 7/16" (11.0 mm) & 9/16" (14.0 mm) diameter, 8 3/4" (22.5 cm)

Evolution®

Evolution® Tibial Base Finish Impactor W/ MOD Connection

Millennium

Malleable Bone Imapacting Grafter Extra Small, OA 11.4" Shaft Length 5.9" Diameter 6.5mm

Trabecular Metal™

7 catalogue numbers from 00-5452-013-39, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Endo-Model Knee System – Instruments

18 catalogue numbers from 15-2538/12, listed by Waldemar Link GmbH & Co. KG, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

V. Mueller

V. Mueller BONE IMPACTOR HEAD DIAMETER 20MM WITH REPLACEABLE NYLON CAPS OVERALL LENGTH 6-1/2 inches 16.5CM

iNSitu™ Hip System

Stem Inserter, Modular, Varus/Valgus Control, 30 Degree Angle

Conserve®

76 catalogue numbers from 48CH56ID, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec Anvil

Catalogue number 4252-2313, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Tools – WFS

Wrist Hook Dorsal Impactor

Polarcup Impactor Interface Sz 61

Catalogue number 351342512161, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Velofix™ Tlif Cage

2 catalogue numbers from TL0510, listed by CG MedTech Co., Ltd., South Korea, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

50 catalogue numbers from 00-5851-097-11, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Invision

Talar Plate Impactor

Enztec Classic OCI – Trinket 3/8-16 UNC-01

Catalogue number 4252-2098, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Ring Retainer

16 catalogue numbers from 110005138, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Cone Impactor Head, Size 1, 12°

Cone Impactor Head, Size 1, 12 degrees

Exactech Femoral Impactor Head

Catalogue number 02-029-19-1310, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Acetabular Straight Handle

2 catalogue numbers from PPENZSTR, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

DJO Surgical

Impactor, Humeral Head Foundation Shoulder

Uknee™

Tibial baseplate trial, #0 Femoral IM guide impactor

Depuy Reach

Depuy Reach Tibial AND Insert Impactor

IPP-ON®

The PIP Fusion handle impactor is used to insert the implant in the distal part.

OrthoMedFlex

Quick Release Head Impactor

Impactor Handle

2 catalogue numbers from 15259, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Novo Surgical

zenith cloward style graft impactor, double-ended, 7/16" (11.0 mm) & 9/16" (14.0 mm) diameter, 8-3/4" (22.5 cm)

Ic-Pin Inserter

Catalogue number 75120903, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

16 catalogue numbers from 0834964, listed by George Tiemann & Co., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Enztec XR Trinket 3/8-24 UNF-03

Catalogue number 4252-2445, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Link Instruments – Impactors, Extractors and Insertion

Orthopaedic implant inserter/extractor, reusable - Megasystem-C Tumor- and Revision System

LPS

LPS Inserter Version Control

Equinoxe

Impactor, Assembly, Humeral Stem

Symmetry Surgical

Symmetry® Impactor, Cloward Style Graft, End Diameters 7/16 in & 9/16 in, Double-Ended, 8 3/4 in

Delta Xtend

DELTA XTEND Central Screw Metaglene insertion tool outer shaft attachment, +2 lateralized, full wedge

Mariner Deformity

Posterior Impactor, 15mm

U2™ Hip

U2 Cup liner impactor, I.D. 28mm

Cinch Modular Attachments

2 catalogue numbers from 31-555618, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

Outer Grip Locking Femoral Implant Impactor

Pyxis 3d Titanium Cage System

3D TLIF Cage Final Impactor

Persona®

Catalogue number 42-5399-091-00, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor TIP LG

4 catalogue numbers from 18285, listed by Biopro, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Generic Surgical Instruments

Cage Impactor, Curved

Head Impactor

Catalogue number 75124444, listed by implantcast GmbH, Germany, under Impactor. 18 manufacturers in China are registered for this product code.

Atrix-C Cervical Allograft Spacer

Forceps Inserter, Lateral Grasp

Tornier Perform

Fracture Spacer Impactor Tip

Enztec Trinket M10x1.50-01

Catalogue number 4252-2357, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

LinkBio Instrument

Impactor Plate, Tibial Cone Extra Small

TJO – Femoral Head Impactor Head

Catalogue number 1342.00.000, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Innesis Peek Cage

Final Impactor

TriVerse Locking Femoral Impactor

Catalogue number 02-039-19-1300, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Intramedullary Plugs

Intramedullary Plug Impactor, unthreaded, L=383 mm, Ø 12 mm

Polarcup Impactor Interface Sz 63

Catalogue number 351342512163, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Modular Liner Impactor Head

Modular Liner Impactor Head, Sz 28mm

Impactor

Marathon XLPE Cemented Cup 36mm Pusher Head

Plasmafit

CUP Insertion Instr.w/Thread M8X1 CVD

Explant™

Catalogue number 00-7053-004-00, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Keystone

Keystone Graft Delivery Instruments CK Pronged Impactor, Straight

Path®

15 catalogue numbers from 20072040, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

General Hip

3 catalogue numbers from 82-0175-084-00, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Impactor

Manual Impaction Handle, DeSoutter

Flat TIP Disimpactor

Catalogue number SSI001456, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

PediatrOS™ FlexTack™/ RigidTack™

PediatrOS FlexTack/ RigidTack Impact connector Size 20 non-sterile

Impactor

43 catalogue numbers from 00-7045-044-00, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Universal Acetabular Threaded Adapter

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

Two-Step Hammertoe

Two-Step Hammer Toe Impactor

b-ONE™ Primary Acetabular System

Poly Liner Impactor Head, 32MM

PyroCarbon PIP Total Joint System

PIP. Impactor. Proximal

General Instruments

Alif Inserter Impaction CAP, Larger Diameter

Medtronic Reusable Instruments

Impactor EX0118012 Straight Graft 10 X 8

M2A 38MM

3 catalogue numbers from 31-103614, listed by Biomet UK Ltd., United Kingdom, under Impactor. 18 manufacturers in China are registered for this product code.

CS2 Acetabular System

Impactor Head, Plastic, Acetabular Insert Impactor, 22mm

Ortholoc®

2 catalogue numbers from 18719209, listed by Microport Orthopedics Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Duraloc

Duraloc Poly Impactor Handle

M2a-Magnum™

12 catalogue numbers from 31-141065, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

M2A Taper Liner Impactor Plate

2 catalogue numbers from 31-103633, listed by Biomet Orthopedics, United States, under Impactor. 18 manufacturers in China are registered for this product code.

Specials

Straight Impactor

Juliet Instrumentation

Angulated Impactor

Irix-C Cervical Integrated Fusion System

Specialty 12MM Irix-C Guided Modular Inserter TIP W/O Stops

Synfix Evolution

Coupling FOR Synfix® Evolution Aiming Device Holder

Polarcup Impactor

Catalogue number 351342512002, listed by Enztec Limited, New Zealand, under Impactor. 18 manufacturers in China are registered for this product code.

Natural-Knee®

17 catalogue numbers from 6290-00-040, listed by Zimmer, Inc., United States, under Impactor. 18 manufacturers in China are registered for this product code.

Ustar II Hip System

Proximal femoral impactor

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