GAT · Suture, Nonabsorbable, Synthetic, Polyethylene

Device class

Class II

Regulation 878.5000

Total clearances

2020-03-02 → 2026-07-01

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.5000

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Arthrex, Inc.	6	0	2022-10-27
Threadstone, LLC	5	1	2026-03-23
Riverpoint Medical	4	1	2025-10-16
Rti Surgical, Inc.	2	1	2025-10-22
Medos International SARL	2	0	2022-04-26
Teleflex Medical	2	1	2026-05-06
Winter Innovations, Inc.	2	1	2026-07-01
S.B.M. Sas (Science & Bio Materials)	1	0	2023-08-03
Shandong Haidike Medical Products Co., Ltd.	1	0	2023-08-25
Arcuro Medical , Ltd.	1	0	2023-08-10
Embody, Inc.	1	0	2023-06-02
Cynosure, LLC	1	0	2023-07-06
Allosource	1	0	2023-06-27
GM Dos Reis Industria e Comercio Ltda.	1	1	2026-02-19
Yunyi (Beijing) Medical Device Co., Ltd.	1	0	2020-03-02
Medacta International S.A.	1	1	2025-09-12
Conmed Corporation	1	0	2022-05-13
Smith & Nephew, Inc.	1	0	2021-02-01

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
99070	CPT	—	High	Nonabsorbable polyethylene sutures typically billed as surgical supplies

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-01	K261021	Winter Innovations, Inc.	EasyWhip Family
2026-05-06	K260775	Teleflex Medical, LLC	Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
2026-03-23	K254275	Threadstone, LLC	HyperSuture All Green Extension Line
2026-02-19	K254188	GM Dos Reis Industria e Comercio Ltda.	Meniscus Versaflex
2025-10-22	K253145	Rti Surgical, Inc.	Pre-Sutured Tendon
2025-10-16	K253024	Riverpoint Medical	ProZip Knotless Implant
2025-09-12	K252225	Medacta International S.A.	PowerKnot High Strength Sutures
2025-08-13	K252201	Riverpoint Medical	HS Fiber
2025-03-27	K242201	Threadstone, LLC	HyperSuture White/Green Extension Line
2024-08-09	K241376	Threadstone, LLC	HyperSuture All Blue Extension Line
2024-05-10	K234079	Threadstone, LLC	HyperSuture Extension Line
2024-01-05	K231163	Riverpoint Medical	HS Fiber Sutures
2023-11-24	K230311	Threadstone, LLC	HyperSuture
2023-08-25	K231183	Shandong Haidike Medical Products Co., Ltd.	Non absorbable Surgical Polyester Suture
2023-08-10	K223500	Arcuro Medical , Ltd.	SuperBall Meniscal Repair System
2023-08-03	K223122	S.B.M. Sas (Science & Bio Materials)	MENIX®; MENIX® DUO
2023-07-06	K230510	Cynosure, LLC	MyEllevate
2023-06-27	K213046	Allosource	AceConnex Pre-Sutured Fascia
2023-06-23	K230036	Rti Surgical, Inc.	Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
2023-06-02	K223822	Embody, Inc.	ACTIVBRAID
2022-10-27	K220880	Arthrex, Inc.	Arthrex BioSuture
2022-09-14	K222078	Arthrex, Inc.	Arthrex SoftStitch
2022-09-09	K221354	Arthrex, Inc.	Arthrex SutureTape
2022-05-13	K220186	Conmed Corporation	Zone Specific AIM
2022-04-26	K220219	Medos International SARL	PERMALOOP Suture, PERMATAPE Suture