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.

Advance®

644 catalogue numbers from KFPSTR50, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Implant Partners™

170 catalogue numbers from EAT5210LWD, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Profemur®lx

Catalogue number PLX5XR15, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

P.F.C. Sigma

P.F.C. SIGMA CRUCIATE RETAINING FEMORAL TRIAL - NON POROUS SZ 1.5 RT 57mm M/L 53mm A/P

Emphasys

Emphasys Inclination Guide Straight Acetabular Impactor

Pinnacle

PINNACLE TRIAL ACETABULAR LINER CON +4 NEUTRAL 40mm ID 66mm OD

Cslp

Template F/TI Cervical Spine Locking Plate 88MM (80MM)

ACF

ACF Stick Trial Spacer Monoplanar STOP/LORDOTIC/11MM

AcuMatch

Acumatch Collared Medium Neck Trial Second Offset

Equinoxe

Humeral Augmented Tray Trial, +0 Lateralized, Right, Captured Screw

Vantage

Low-Profile Talar Implant Trial, Size 1, Right

K2M General Instruments

Lordotic Modular Trial, Size 22x60x14 mm, 12°

Evolution®

Evolution® KA Distal Reference Curved EXT GAP Spacer 1MM

BIO-Modular Choice Instruments

17 catalogue numbers from 406740, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Axiom®

408 catalogue numbers from 2278008500, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Contact PEEK IBF System

56 catalogue numbers from 34-TRL40-18-8, listed by Pioneer Surgical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

TiWave C Cervical Cage System

Cervical trial, anatomic, 13mm x 12mm, 10mm, 14 degree, extra tapered

Tornier Perform

Fracture XRO Humeral Head Trial

Evos

Evos 3.5MM/4.5MM Periprosthetic Trochanteric Ring Femur Span Template L 20H 440MM

Journey II

Journey II BCS Constrained Insert Trial SZ 1-2 10MM Right

OSS™

149 catalogue numbers from 32-472030, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Salto Talaris Total Ankle Prosthesis

Salto Talaris. Talar Trial. Flat CUT. Size 1. Left

Trabecular Metal®

106 catalogue numbers from 7111-58-36, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Template

792 catalogue numbers from 5841-01-02, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

NexGen®

336 catalogue numbers from 5881-40-26, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Timberline Lateral Fusion System

Trial Rasp Lateral 0DEG 16MM X 12MM

Enduro

Enduro Trial Femur Stem D12X117 Cem.less

Link Instruments – Trial Implants and Size Gauges

549 catalogue numbers from 15-3211/28, listed by Waldemar Link GmbH & Co. KG, Germany, under Template. 21 manufacturers in China are registered for this product code.

Vantage®, Activit-E

Liner Trial

Endoskeleton® TA

Trial, 12 Deg Lordotic, Standard, 17mm

Fortilink-TC IBF System

34 catalogue numbers from 65-TC-T26-9-6L, listed by Pioneer Surgical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

4WEB Medical

991 catalogue numbers from PSTS-SM1815-26S, listed by 4WEB Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Vega System PS

Vega PS Trial Gliding Surface T1/1+ 12MM

Made-To-Order

Simpliciti Postless Trial Head

Vang XP Fmrl 4IN1 CUT BLK

12 catalogue numbers from SSI002603, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Specials

Lollipop Trial, Right/Down-Angled, 18mm x 13mm x 55mm, 10°

Tranquil-L™

Tranquil-L ALIF Trial 18x36x28, 12 deg

Alif

Alif Trial Spacer-Quick Release 15MM Height

Odyssey®

67 catalogue numbers from KTBTRL60, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Template

Instrument 7351171 Hook Trial Extnd Body

Revision Knee System

RKS, Distal Fem Cut Guide, 0-5mm Femoral/0-10mm Tibial

Consensus Knee System/Revision Knee System

CKS, Trial, Tibial Insert, PCL Substituting, Sz 3/4, Right, 14mm

UniSyn Hip System

Fixed Body, Neck Positioner, UniSyn, Right, 20 Degrees

CS2 Acetabular System

Trial, Acetabular Insert, Rimmed, 20 Degree Hooded, 28/68mm

LCS Completion

LCS Completion REVISION POSTERIOR AUGMENT TRIAL LG/LG+ 10mm

Attune

ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 14mm

Synfix Evolution

Synfix® Evolution Trial Spacer Large DEEP/13.5MM HEIGHT/10°

Stable-L™

Stable-L Trial, 30x24x20, 24 deg

MaxFuse PEEK VBR System

MAXFUSE, 14.5x17x4850 REPLICA TRL SPACER

Lospa TKR System

LOSPA Tibial Insert Trial CR #03 T08

Global Steptech APG

GLOBAL STEPTECH APG TRIAL SIZE 48 +5mm RIGHT

Aclp

Template FOR Anterior Cervical Plates 4 Level (100MM)

Template

MTO Drill Guide Adaptor Remvbl TWN TNL

Merge OrthoTemplates

Software implant template

Template

TRIAL, FEMORAL AUG. BLOCK, SCREW FIXATION, POSTERIOR SZ 1-3, 10mm

Template

SURGICAL TITANIUM MESH (ST) OBLONG GRAFT TRIAL 12 x 23mm x (14 x 16mm)

MicroPort

Hipturn FEM Head Trial 36MM Reusable

Inertia® Pedicle Screw and Deformity Correxxion® System

Crosslynxx Measuring Template

Sigma

Sigma High Performance Fixed Reference Posterior Rotation Guide 0 DEG

Lordotic Trial Sizer 18×14, H12mm

Catalogue number RO1478LF1218X14, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

Aegis

AEGIS ANTERIOR LUMBAR PLATE TRIAL 15mm/17mm

CeMend Shoulder Spacer Trial 12 48

Trial size 12 48

Salto Talaris®

Total Ankle Prosthesis Drill Bit, 3 mm Dia. X 135 mm

Attune

ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 10, 3MM

Ortholoc®

110 catalogue numbers from 18730526, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Profemur®

591 catalogue numbers from APA09006, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

T-Plus Peek VBR/IBF System

14mm Trial Spacer

Fortilink-C IBF System

39 catalogue numbers from 65-C-TRL-S-10-10L, listed by Pioneer Surgical Technology, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Arthrex®

TRL F/ Vertical Shear Dist TIB PLT,TI,4H

U2 Total Knee System

Patella sizing ring, asymmetric onset, NON-CEM, L/XL, 35/38mm

Ringloc Screw-IN

4 catalogue numbers from 31-115805, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Max-Ti® Acetabular Reconstructive System

19 catalogue numbers from 124092, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Template

FEM SLEEVE TO LPS DIST FEM TRIAL ADAPTER +10mm

Apex Knee System

EVO Tibial Tray Trial for punch dart w additional mantle sz 3L

Plasmacup SC

Plasmacup SC X-RAY TEMPL.SZ.56-62MM P.W.

Alloquent – Alif

Distractor Trial Spacer 20MM Alloquent Alif 7 Degree

Evolve Proline

Proline Modular Radial Head

SLR

71 catalogue numbers from 18070002, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Bipolar Hip System

Bipolar Femoral Head Trial, 22mm, Sz 40

Advantim®

276 catalogue numbers from 18710010, listed by Microport Orthopedics Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

S-ROM

S-ROM Distal Stem Trial, X-Long - Neutral Size 15

DVR® Anatomic Standard Head Left Trial

Catalogue number 2312-12-102, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Endo-Model Knee System – Instruments

Body femoral/tibial extension stem, uncoated - Endo Model Rotational and Hinge Knee System

Alteon

Alteon Mono Revstm Trial Size 22X295

Tornier Flex

AEQUALIS™ HUMERAL HEAD XRo TRIAL

NexGen® Legacy®

242 catalogue numbers from 5961-31-17, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Honour™ Spacer System

Elite Non-Recessed, Cervical Trial Drill Guide, 0°, 14x16x7

Eleos™

Resurfacing Patella Minimum Thickness Gauge 10MM

Trial CUP D80 Mm

2 catalogue numbers from 9055.28.480, listed by HPF SRL, under Template. 21 manufacturers in China are registered for this product code.

Integra® BioMotion®

The BioMotion cannulated hemi sizer allows for clear visualization of the implant size to anticipate bone removal.

LCS

LCS High Performance Instruments Femoral Finishing Guide Without Feet STD+

Ringloc+ 10 Degree Trial Liner

30 catalogue numbers from 33-117845, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Alta Acdf System

Timberline Trial Implant Lateral 20° 22 x 14

MAX-TI Acetabular

12 catalogue numbers from 124092, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

OSS IM Total Femur Trial

11 catalogue numbers from 32-472699, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

Self Centering

SELF CENTERING MODULAR CATHCART MOD HEMI HIP HEAD TRIAL 53OD x 22.225ID

Intuition

Intuition FOR HP Partial Tibial Template Size - Left Medial/Right Lateral 3

Template

Bending Template 6 X 23 Holes F/Angled Reconstruction Plates

Anatomic Trial Sizer 16×12, H08mm

Catalogue number RO1234AC0816X12, listed by Spineup Inc, United States, under Template. 21 manufacturers in China are registered for this product code.

ProPlan CMF

Patient Specific Splint and Planning Kit, Orthognathic Kit, two Splints

Columbus Revision

COL REV Trial HEMI-SPCR.T1/1+ 15MM RL/LM

Inlet System Surgical Instrument

9 catalogue numbers from IN24-STST-008T, listed by Jeil Medical Corporation, South Korea, under Template. 21 manufacturers in China are registered for this product code.

Specialist

SPECIALIST 2 FEM REV A/P CUTTING GDE BUSHING-OFFSET +2mm & -2mm 7 DEG

Alif Vertigraft

Universal Alif Instrument SET Vertigraft Trial, Anterior 14

Tranquil-C™

Cervical Trial +DS 10x16x13 Lordotic – No DS

Irix-A Lumbar Integrated Fusion System

11 MM Specialty 38X28X12 DEG Irix A Modular Trial Head

Endoskeleton® TAS

Trial, Anterolateral, 12 Deg Lordotic, Standard, 17mm

Donor Template

Catalogue number Donor template, listed by Cole Instruments, United States, under Template. 21 manufacturers in China are registered for this product code.

Razor Femoral Head Trial

36mm Femoral Head Trials

High Mobility Mini Humeral Bearing Trial 40mm STD

Catalogue number SSI007240, listed by Zimmer, Inc., United States, under Template. 21 manufacturers in China are registered for this product code.

Infinity

Tibial Tray Impact Insert

Titan™

The Head Sizing Plate is used to find the base width, along with the need for a concentric or eccentric head, prior to trialing the humeral head.

Endoskeleton® TCS

Trial, 6 Deg Lordotic, Medium, 11mm

IdentiTi

Alif Inst, Template Tool, 34

VA-LCP

Sizing Template F/2.4MM VA-LCP 2-COL Dstl RAD PL NRW 6H HD/L

Invictus

Template, Offset Hook, Right, Narrow Long, 10.5 mm

LP Ringloc(R) Provisional Liner

8 catalogue numbers from 31-423579, listed by Biomet Orthopedics, United States, under Template. 21 manufacturers in China are registered for this product code.

MD Vue Discectomy

Angled Trial Rasp 22 x 12 mm 7°, L UP

Aesculap

SC/MSC Trial Insert 32MM 56/58 Post.wall

Surgical Instrument

212 catalogue numbers from ACSA-C-151708, listed by Jeil Medical Corporation, South Korea, under Template. 21 manufacturers in China are registered for this product code.

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