Who else makes this device?

Orthopedic › ProstheticPin, Fixation, Smooth

0.062″X 4.65″ Olive Wire Partially Threaded

Catalogue number 320-60-005, listed by Trilliant Surgical LLC, United States, under Pin, Fixation, Smooth. 12 manufacturers in China are registered for this product code.

Registry build 21.09.26

12manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTY
Manufacturer	City	Province	Registered as	Device types
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Suzhou Kangli Orthopaedics Instrument Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	11
Kingj Medical Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	7
Aplus (Guangzhou) Medical Technology Company	Guangzhou	Guangdong	Contract manufacturer	6
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for 0.062″ x 4.65″ Olive Wire Partially Threaded
Listed by	Trilliant Surgical LLC, United States
FDA product code	HTY
Device type	Pin, Fixation, Smooth
Device class	Class 2
Regulation	21 CFR 888.3040
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K160177
Record published	2017-07-27
Record revised	2024-02-19 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for 0.062″ x 4.65″ Olive Wire Partially Threaded
Catalogue number	Size	Status
320-60-005	0.062″ x 4.65″ Olive Wire Partially Threaded	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Rondo’	Citieffe SRL	265
HNM Medical	HNM Stainless, LLC.	232
Kmedic	Teleflex Medical LLC	227
gSource	Gsource, LLC.	221
MicroAire®	Microaire Surgical Instruments LLC	213
Orthomed	Ortho-MED, Inc.	163
mahe medical GmbH	Mahe Intl., Inc.	160
Pin, Fixation, Smooth	Key Surgical, LLC	134
Pin, Fixation, Smooth	Stryker GmbH	134
Aptus	Medartis Inc.	134
Key Surgical K-Wires and Steinmann Pins	Key Surgical, LLC	126
PedFlex Flexible Nailing System	Orthopediatrics, Corp	119

Showing 12 of 682. All products under Pin, Fixation, Smooth

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K121008	2012-06-04

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-11-04	Class II	Mixed-up of materials/components	The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex	117	2021-04-28

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.