Who else makes this device?

Name: Signature
Brand: Signature

Signature · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer → Orthopedic

10manufacturers in China registered for this device type

23catalogue numbers in this listing

1510(k) clearance

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 Signature
Listed by	Materialise NV, Belgium
FDA product code	HRY
Device type	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3530
510(k)	K110415
Record published	2016-09-24
Record revised	2019-11-27 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization, Hydrogen Peroxide
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2017-07-21

Catalogue Numbers

Catalogue numbers for Signature
Catalogue number	Size	Status
42-422761		Withdrawn
42-411574		Withdrawn
42-411572		Withdrawn
42-422772		Withdrawn
42-422773		Withdrawn
42-422752		Withdrawn
42-422763		Withdrawn
42-422750		Withdrawn
42-422760		Withdrawn
42-422751		Withdrawn
42-411562		Withdrawn
42-411564		Withdrawn
42-411563		Withdrawn
42-411570		Withdrawn
42-411573		Withdrawn
42-422771		Withdrawn
42-411560		Withdrawn
42-411561		Withdrawn
42-422410		Withdrawn
42-422753		Withdrawn
42-422762		Withdrawn
42-422770		Withdrawn
42-411571		Withdrawn

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
K110415	2011-05-16

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 Signature
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Materialise USA, LLC.	510(k) number	2013-11-26	Class II	Nonconforming Material/Component	Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.	1	2014-01-14

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.

Signature