Template

Which Manufacturers in China Make This?

11 of the 21 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, Shanghai and Fujian, and 4 other provinces.

Arthrex (Shanghai) Co., Ltd. Shanghai
B-ONE Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
Beijing Fule Science & Technology Development Co., Ltd. Beijing
Canwell Medical Co., Ltd. Zhejiang, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Double Medical Technology Inc. Fujian, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Guangzhou Clean Medical Products Manufacturing Corp 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
Suzhou AND Science & Technology Development Corp. Jiangsu, contract manufacturer
Suzhou Microport Orthorecon Co., Ltd. Jiangsu, contract manufacturer
Sanbor Medical Xiamen, Inc. Fujian, contract manufacturer
Suzhou Ahno Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Suzhou Elite Precision Machinery Co., Ltd. Jiangsu, contract manufacturer
Xinhua Healthcare Industry Co., Limited Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HWT?

Template is FDA product code HWT, Class 1, 21 CFR 888.4800.

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 85 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (47), Process control (9) and Employee error (5).

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

JII UK

SZ 10 Medial Tibia Implant Trial - RT

Legion

Legion REV Monoblock Constrained Insert Trial W/Jrny Lock SZ 5-6 11MM

RingLoc® + Max-Rom™

47 catalogue numbers from 31-108425, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Cross-Fuse® II PEEK VBR/IBF System

L4/L5 Trial Spacer, Right

Lordotic Trial Sizer With Stop 16×14, H05mm

Catalogue number RO0541L20516X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Template

Troch Nail, 3.0mm Pre- bent Ball Tip Guide Rod, 1000mm, Sterile

Duraloc

DURALOC SCREW-IN TRIAL LINER 28mm ID 64mm OD 10 DEGREE

Alamo P

Trial Shaft Instrument

Versanail®core Tibial Tray

Catalogue number 2810-12-029, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

MaxLock

OrthoLink™ MEDIAL WEDGE PLATE TEMPLATE

Solution System

SOLUTION SYSTEM 10 INCHES BOWED TRIAL-LARGE 45 OFFSET RIGHT 16.5mm

Procotyl®

34 catalogue numbers from APA09384, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

MAX-ROM(TM) Ringloc(R) Prov. Liner

11 catalogue numbers from 31-156238, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Pediflex

Ø1.5mm Flexible IM Nail Template

Inhance Shoulder System

INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL KIT 38 - 44mm NA

Aetos Shoulder System

42MM Glenosphere TRL Concentric +3MM

Truliant

Special Spiked Truliant Tibial Tray Trial, Size 1.5

Lordotic Trial Sizer 20×12, H11mm

Catalogue number RO1497LG1120X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Oxford UNI Knee System

10 catalogue numbers from 32-422843, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Versys Prov G7 STY

28 catalogue numbers from SSI005956, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

PRO

Trial Posterior Rim Plate, 2-hole narrow

BI-Metric Provisional

28 catalogue numbers from 31-473456, listed by Biomet UK Ltd., United Kingdom, under Template. 21 manufacturers in China are registered for this product code.

Custom

IMPIX-TLIF TRIAL WITH SLAP HAMMER 13mm

Freedom® RingLoc®

18 catalogue numbers from 31-107324, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Precice® Plating System

PRECICE Plate Template Posteromedial Tibia, R

Pulse

PULSE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL SIZING TEMPLATE 42/45mm

Endoskeleton® TC

Trial, 6 Deg Lordotic, Medium, 10mm

PST LSS TC PRV NCK Assy HO 18-24

Catalogue number SSI006942, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Maxim Provisional Tibial Bearing

38 catalogue numbers from 32-343184, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

TiWAVE L Lumbar Cage System

Trial, 20 x 10mm, 15 Degree, Extra Tapered, Straight

Baby Gorilla/Gorilla Plating System

Gorilla, Ankle Fracture, Hook Plate Template, Lateral Mal.

Vanguard®

178 catalogue numbers from 32-484264, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Maestro(TM) Total Wrist

22 catalogue numbers from 409183, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Aleutian® Interbody Systems

Parallel Rasp Size 18x45x17 mm

Triverse Tibia Insert Trial Combo, 59×20

Catalogue number 122-22-8560, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Interseal®

74 catalogue numbers from 3000XR15, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Ringloc(R) Provisional Liner

29 catalogue numbers from 31-423694, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

JII

Modified JII Tibia Cutting Block Right

P.F.C.

P.F.C. Offset Tibial Noncemented Punch Guide Size 1.5 - 3

Flower Orthopedics

Template, Olecranon Plate, Bowed, 11-Hole, Right

Medtronic Reusable Instruments

Trial X0110611 6DEG Lordotic Medium 11MM

Regenerex(TM) Ringloc®+ Acetabular CUP

7 catalogue numbers from 31-400680, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Saber Lumbar I/F Cage

SABER LUMBAR I/F CAGE SYSTEM RASP/TRIAL 13 x 12mm

Trial CUP D39 Mm

2 catalogue numbers from 9055.28.439, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Template

trial cup insert 10° offset 5 mm incl. Screw

Evolution Revision CCK System

66 catalogue numbers from E1708351, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Bullet-TIP Peek IBF System

Detachable Trial Spacer

MatrixMANDIBLE

Matrixmandible Bendng Template FOR Narrow Tension Band Plate

Uni

LL JII UK TIB Trial SZ 0 W/ Post

Harmony

Universal Tibial Base Trial SZ 5 Right

Made-To-Order

Allopure Cotton Wedge Trial

Impix-Alif S/A

IMPIX ALIF S/A TRIAL MEDIUM 14mm - 12°

Titan Modular Shoulder System 2.5

TSS Definitive Stem Fracture Body Trial LRG. 2.5

Ringloc®+ HI-Wall Liner Provisional

16 catalogue numbers from 33-195236, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Template

Mobility TRIAL INSERT SZ 6 - 11mm

Pinnacle Gription TF

Pinnacle Gription TF Augment Adjustable Handle

Ringloc Locking Liner Provisional

28 catalogue numbers from 31-413714, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Juliet ® Instrumentation

TRIAL IMPLANT Ti PO/OL SMOOTH SMALL WIDTH

Allure Hip Stem

Allure, Trial Neck Segment, high offset, Sz. 11-13, CCD 130°, Taper 12/14 mm

Tahoe Unicompartmental Knee System

TUKS, Tibial Cut Block, Noncaptured, RM/LL, Extra Patella CLR, ASSY

Consensus Knee System

CKS, Captured Distal Femoral Cut Block, Quarter Turn Lock, 0.89mm SLOT

Vanguard(TM)

96 catalogue numbers from 32-484100, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

ZUK

Tibial Drill Guide Size 4 Left Medial/Right Lateral

Tornier Perform Humeral System

10° Reversed Insert Trial, 65%

Global Unite

Global Unite FX Reverse Shoulder Arthroplasty Cutting Guide Right

Continuum® Trilogy®

19 catalogue numbers from 00-8791-062-00, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Solution System Articul/EZE

SOLUTION SYSTEM ARTICUL/EZE CALCAR TRIAL STEM 12/14 TAPER 16.5mm x 9in 2.25cm RIGHT

Intervertebral Body Fusion Device

ALIF Sizer 15 degree 17mm x 39mm

Bencox

Template Bencox ID Cementless Stem 115%

Titan Modular Shoulder System

Definitive Stem Primary Body Trial 14LRG

Offset Modular Head Provisional

9 catalogue numbers from 31-163543, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

C-Plus PEEK IBF System

C-PLUS, 15X17 L2L TRIAL SPACER, 10mm

Perfecta®

111 catalogue numbers from 4700TN28, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Implant Style +5 Ring-LOC

17 catalogue numbers from 31-103914, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Plasmafit

Plasmafit Tray F/Module Trial Cups

Link Instrument

Trial Shell/Insert Adapter

Level ONE CMF

Template, Orthog, STR, FOR 25-551-04-XX, 25-752-04-XX, AND 50-321-04-XX, Aluminum

XT Revision Ankle Replacement System

Integra XT. Sloped Talar Trial. Size 1. Right

Journey II Fastpak

Journey II Fastpak Size 1-2 Right Insert Trials AND Spacers 9-13,15 MM

GII

GII Thinned Spacer Block

Journey

Journey II Articular Stabilized Articular Insert Trial Size 3-4 Right 10MM

28MM Endo II Modular Head Trial

5 catalogue numbers from 31-401161, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

AGC Molded Tibial Template

5 catalogue numbers from 32-349064, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Maxim Primary Femoral Component

10 catalogue numbers from 32-340030, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Impix-Manta

TRIAL KIT FOR IMPIX-MANTA MEDIUM (H: 4, 5, 6, 7mm)

VerSys®

137 catalogue numbers from 7893-14-08, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Conserve®

204 catalogue numbers from 48021853, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Scarlet AC-T Instrumentation

Trial Large - Lordotic

ACS®

PS femoral trial component S 2,5 right

TriVerse Modular Tray Trial

18 catalogue numbers from 02-039-25-1063, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Distraction, Internal, Sterile

Sizer, FOR 51-425-15-71, 51-425-20-71, 51-425-25-71 AND 51-425-30-71, Titanium

Maxim

17 catalogue numbers from 32-341225, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Tornier HRS

Humeral Head Coupler Trial

Optetrak Logic

TRIAL, CR TIBIAL INSERT, LOGIC®, SIZE 1.5, 13mm, SLOPE ++

Aria Size 1 Template

Catalogue number 111-201-501, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Evolve Stem Template – Size 5

Catalogue number 112-184-546, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Optio-C Anterior Cervical System

Lordotic Trial

Explorer TO

12mm Trial, 9mm Wide, Centered

RingLoc® +

91 catalogue numbers from 33-116867, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

LinkSymphoKnee – Instruments

316 catalogue numbers from 881-131/10, listed by Waldemar Link GmbH & Co. KG, Germany, under Template. 21 manufacturers in China are registered for this product code.

OSS 7CM Elliptical Proximal Femoral

2 catalogue numbers from 32-472125, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Tools – FPS

Universal Cobra Hook Plt, 5-Hole, Template

Triverse Tibia Insert Trial Combo, 59×22

Catalogue number 122-22-8562, listed by Signature Orthopaedics PTY Limited, Australia, under Template. 21 manufacturers in China are registered for this product code.

Tornier Radial Head System

Trial Head

G7 Snap-In Neutral Prov Size 28 A

2 catalogue numbers from SSI008222, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Cougar

COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE TRIAL 18 x 14mm, 15 DEGREES

Bengal

Bengal Stackable Cage System Cage Trial, Extra Large

Cougar

COUGAR LS LATERAL INTERBODY INSTRUMENT SYSTEM ANGLED TRIAL 14mm

Variax

Plate Trial Elbow for Distal Lateral Humerus , Right

Cespace

Cespace Bone Trial 11X16X13.5MM,PARALLEL

DJO Surgical

Special, Empowr REV Knee Monoblock Tibial Tray Trial, SZ 10L

PPS® RingLoc® +

39 catalogue numbers from 33-433742, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Dynasty®

Dynasty® Dual Mobility Trial Liner Group C 38mm

Quantum

QUANTUM Tibial Stem Cruciform Guide Right Size 4

MaxAn Anterior Cervical Plate System

4-LVL 104MM Plate Template

Gender Solutions® Natural-Knee®

107 catalogue numbers from 00-5425-013-13, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Invision

Talar Plate Trial Spacer

Vanguard(TM) RP 1ST Trial Tray

8 catalogue numbers from 32-488605, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Instrument

Restoration Modular Revision Hip System - Conical Distal Stem (Straight) 115mm Template

Sigma

Sigma High Performance Flexion/Extension Spacer BLK Shim SZ 6

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