Who else makes this device?

Name: Specialty Triathlon TS Cutting Guide Size 8
Brand: Specialty Triathlon TS Cutting Guide Size 8

Orthopedic › ProstheticProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Specialty Triathlon TS Cutting Guide Size 8

Catalogue number I-K4275CG08, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRY
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
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
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
Suzhou Microport Orthorecon Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	31

Record

Regulatory record for Specialty Triathlon TS Cutting Guide Size 8
Listed by	Howmedica Osteonics Corp, United States
FDA product code	HRY
Device type	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3530
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer
Record published	2022-02-21
Record revised	2023-05-03 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Specialty Triathlon TS Cutting Guide Size 8
Catalogue number	Size	Status
I-K4275CG08	Size: 8	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Legion	Smith & Nephew, Inc.	1,682
Genesis II	Smith & Nephew, Inc.	615
Journey II	Smith & Nephew, Inc.	581
Evolution	Microport Orthopedics Inc.	311
Profix	Smith & Nephew, Inc.	293
Journey	Smith & Nephew, Inc.	215
LinkSymphoKnee	Waldemar Link GmbH & Co. KG	201
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Smith & Nephew, Inc.	160
JII	Smith & Nephew, Inc.	141
Physica KR	Limacorporate	128
Physica LMC	Limacorporate	120
Implant Partners	Microport Orthopedics Inc.	119

Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K082567	2008-10-03
K071881	2007-10-09

Recalls

The FDA has not published a severity grade for these. 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
2008-11-25	Not classified	Labeling mix-ups	Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.	8 mm – 1 unit; 12 mm – 8 units.	2010-08-30

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P840049	1988-09-30	P.C.A.(TM) TOTAL KNEE SYSTEM	Howmedica Corp.

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.