Who else makes this device?

Name: Trident II
Brand: Trident II

Trident II · Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer → Orthopedic

10manufacturers in China registered for this device type

7catalogue numbers in this listing

4510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWZ
Manufacturer	City	Province	Registered as	Device types
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
APS Materials Suzhou	Suzhou	Jiangsu	Contract manufacturer	18
Xian Airfoil Technology Co., Ltd.	Xian	Shaanxi	Contract manufacturer	8
Lincotek (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	7
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

Record

Regulatory record for Trident II
Listed by	Howmedica Osteonics Corp, United States
FDA product code	KWZ
Device type	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3310
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Manufacturer
Record published	2018-02-12
Record revised	2025-02-06 (version 7)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Sizes	Outer diameter 48 to 66 mm; length 30 mm

Catalogue Numbers

Catalogue numbers for Trident II
Catalogue number	Size	Status
742-11-50D	Alpha Code: D	In distribution
742-11-64H	Number of Screw Holes: 5.0 Holes	In distribution
702-04-66H	Outer Diameter 66.0 mm	In distribution
700-04-62G	Alpha Code: G	In distribution
702-11-56F	Outer Diameter 56.0 mm	In distribution
702-11-48D	Alpha Code: D	In distribution
7030-6530	Diameter: 6.5 Millimeter	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DJO Surgical	Encore Medical, L.P.	159
Instrument	Howmedica Osteonics Corp	139
ZMR®	Zimmer, Inc.	103
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Zimmer, Inc.	69
Arcos Modular Revision System	Biomet Orthopedics	66
Pinnacle	Depuy Orthopaedics, Inc.	52
System 12	Howmedica Osteonics Corp	47
Restoration	Howmedica Osteonics Corp	46
Redapt	Smith & Nephew, Inc.	43
R3	Smith & Nephew, Inc.	41
Trident	Howmedica Osteonics Corp	38
Arcos Modular Revision Hip System	Biomet Orthopedics	37

Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K063445	2007-03-08
K063550	2007-03-08
K063552	2007-03-08
K061654	2006-07-07

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Trident II
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Howmedica Osteonics Corp	UDI-DI	2024-02-27	Class II	Under Investigation by firm	The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell	45 units
Howmedica Osteonics Corp	UDI-DI	2024-02-27	Class II	Under Investigation by firm	The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell	0
Howmedica Osteonics Corp	UDI-DI	2024-02-27	Class II	Under Investigation by firm	The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell	0

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
2026-07-30	Not classified	Process change control	Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to	12,156 US

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
P960054	1997-06-19	S-ROM POLY-DIAL CONSTRAINED LINER	Depuy, A Johnson & Johnson Co.

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.

Trident II