Who else makes this device?

Name: Retention Device, Suture
Brand: Retention Device, Suture

Retention Device, Suture → General & Plastic Surgery

3manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (1).

Chinese manufacturers registered for FDA product code KGS
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Mediunion Healthcare Group Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	105
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82

Record

Regulatory record for Retention Device, Suture
Listed by	Smith & Nephew, Inc., United States
FDA product code	KGS
Device type	Retention Device, Suture
Device class	Class 1
Regulation	21 CFR 878.4930
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2015-08-30
Record revised	2023-09-07 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Box of 6

Catalogue Numbers

Catalogue numbers for Retention Device, Suture
Catalogue number	Size	Status
013636		In distribution
013635		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bioseal Inc.	Bioseal	20
Xtendobutton	Smith & Nephew, Inc.	7
Dynamic Tissue Systems™	Southmedic, Inc.	4
Vive	Vive Health LLC	2
Perchik	AngioDynamics, Inc.	2
FlowStasis	Inari Medical, Inc.	2
Stent Buttons	Boston Medical Products, Inc.	2
Medline Industries, Inc.	Medline Industries, Inc.	2
Medline	Medline Industries, Inc.	2
Slip-Not®	Merit Medical Systems, Inc.	2
Poly Suture Button	Biomet Sports Medicine	2
StarGuard Suture Retention Plates – 9″	Preservation Solutions, Inc.	1

Showing 12 of 29. All products under Retention Device, Suture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K020480	2002-03-12

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
2006-03-24	Not classified	Other	The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.	1800 units	2007-12-12

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.

Retention Device, Suture