Who else makes this device?

Name: Pin, Fixation, Smooth
Brand: Pin, Fixation, Smooth

Pin, Fixation, Smooth → Orthopedic

12manufacturers in China registered for this device type

104catalogue numbers in this listing

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 Pin, Fixation, Smooth
Listed by	Synthes (U.S.A.) LP
FDA product code	HTY
Device type	Pin, Fixation, Smooth
Device class	Class 2
Regulation	21 CFR 888.3040
510(k)	K914371
Record published	2015-09-14
Record revised	2026-02-09 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2020-07-26

Catalogue Numbers

Catalogue numbers for Pin, Fixation, Smooth
Catalogue number	Size	Status
459.44		Withdrawn
450.703S		Withdrawn
450.867		Withdrawn
450.867S		Withdrawn
459.28S		Withdrawn
450.788S		Withdrawn
450.866		Withdrawn
450.830S		Withdrawn
450.856S		Withdrawn
450.783S		Withdrawn
459.56S		Withdrawn
474.031S		Withdrawn
450.875S		Withdrawn
450.871S		Withdrawn
450.708S		Withdrawn
450.834S		Withdrawn
474.922S		Withdrawn
450.715S		Withdrawn
450.869		Withdrawn
459.46		Withdrawn
450.872S		Withdrawn
450.790S		Withdrawn
474.048S		Withdrawn
459.50S		Withdrawn
450.829S		Withdrawn
474.136S		Withdrawn
450.804S		Withdrawn
450.861		Withdrawn
450.868		Withdrawn
450.702S		Withdrawn
450.809S		Withdrawn
450.831S		Withdrawn
450.786S		Withdrawn
459.46S		Withdrawn
450.861S		Withdrawn
450.714S		Withdrawn
474.044S		Withdrawn
474.921S		Withdrawn
474.141S		Withdrawn
459.95S		Withdrawn
474.242S		Withdrawn
450.828S		Withdrawn
450.873S		Withdrawn
450.826S		Withdrawn
474.541S		Withdrawn
450.873		Withdrawn
459.100S		Withdrawn
450.796S		Withdrawn
450.865		Withdrawn
450.869S		Withdrawn
450.864S		Withdrawn
450.866S		Withdrawn
459.42S		Withdrawn
474.913		Withdrawn
450.862S		Withdrawn
450.871		Withdrawn
450.870		Withdrawn
450.865S		Withdrawn
459.48		Withdrawn
450.868S		Withdrawn
450.875		Withdrawn
450.874		Withdrawn
450.855S		Withdrawn
474.138S		Withdrawn
474.900S		Withdrawn
450.705S		Withdrawn
450.844S		Withdrawn
459.85S		Withdrawn
450.716S		Withdrawn
450.713S		Withdrawn
474.910S		Withdrawn
450.814S		Withdrawn
459.58S		Withdrawn
450.827S		Withdrawn
450.862		Withdrawn
450.712S		Withdrawn
450.864		Withdrawn
450.808S		Withdrawn
459.56		Withdrawn
474.913S		Withdrawn
450.872		Withdrawn
459.60S		Withdrawn
450.791S		Withdrawn
450.701S		Withdrawn
450.870S		Withdrawn
474.144S		Withdrawn
474.334S		Withdrawn
450.824S		Withdrawn
450.785S		Withdrawn
450.851S		Withdrawn
474.134S		Withdrawn
474.146S		Withdrawn
450.896		Withdrawn
450.782S		Withdrawn
474.338S		Withdrawn
474.910		Withdrawn
450.846S		Withdrawn
459.36		Withdrawn
474.532S		Withdrawn
450.863		Withdrawn
450.787S		Withdrawn
450.848S		Withdrawn
450.789S		Withdrawn
450.784S		Withdrawn

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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Pin, Fixation, Smooth
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Synthes USA (HQ), Inc.	510(k) number	2013-04-18	Class II	Packaging process control	Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.	1	2015-03-30

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.

Pin, Fixation, Smooth