MBI · Fastener, Fixation, Nondegradable, Soft Tissue

Device class

Class II

Regulation 888.3040

Total clearances

197

2020-01-02 → 2026-08-03

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3040

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.	26	6	2026-06-26
Riverpoint Medical	20	2	2026-03-11
Paragon 28, Inc.	11	2	2026-08-03
Medacta International S.A.	11	0	2025-07-01
Responsive Arthroscopy, Inc.	8	2	2026-07-20
Parcus Medical, LLC	8	0	2022-07-26
Smith & Nephew	8	1	2026-07-09
Stryker Endoscopy	7	1	2026-07-30
Osteonic Co., Ltd.	6	0	2024-12-03
Aevumed, Inc.	6	3	2026-03-04
Conmed Corporation	6	2	2026-05-13
Medos International SARL	5	0	2023-10-06
Tigon Medical	5	2	2026-04-21
Healthium Medtech Limited	5	0	2024-01-04
Abanza Tecnomed S.L	4	1	2026-01-06
Suzhou Endophix Co., Ltd.	4	0	2024-05-03
Biomet, Inc.	4	0	2020-11-10
Auxein Medical Private Limited	4	0	2022-12-16
Ots Medical , Ltd.	3	0	2025-07-22
T.A.G. Medical Products Corporation, Ltd.	3	0	2022-09-07
Aju Pharm Co., Ltd.	3	0	2024-08-02
Ortho-Design (Pty), Ltd.	2	0	2024-08-29
Valeris Medical, Inc.	2	0	2020-03-26
ZheJiang Decans Medical Devices Co., Ltd.	2	1	2026-05-27
BAAT Medical Products B.V.	2	1	2026-03-16

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
20670	CPT	—	Medium	CPT for abdominal or retroperitoneal implant; soft tissue fastener codes vary by anatomical location
20680	CPT	—	Medium	CPT for removal and reinsertion of implantable device; soft tissue fastener placement may use this or anatomically specific codes

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-03	K262047	Paragon 28, Inc.	Grappler Suture Anchor System
2026-07-30	K262369	Stryker Endoscopy	AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down
2026-07-29	K261770	Skeletal Dynamics, Inc.	Suture Button Repair System
2026-07-20	K261632	Responsive Arthroscopy, Inc.	Thunderbolt System
2026-07-09	K261968	Smith & Nephew, Inc.	Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
2026-06-26	K260018	Arthrex, Inc.	Arthrex FiberButton
2026-05-27	K253130	ZheJiang Decans Medical Devices Co., Ltd.	Dione PEEK Screw System
2026-05-13	K261363	CONMED Corporation	Y-Knotless Flex Anchors
2026-05-06	K253027	Ortobio S.A.	Anchor with Fiber Wire and Disposable Inserter
2026-05-01	K252635	ArthroTAK, LLC	ArthroTAK Tendon Anchor Kit
2026-04-21	K260921	Tigon Medical	Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
2026-03-20	K260561	Arthrex, Inc.	Arthrex FiberTak Suture Anchor
2026-03-17	K253886	Paragon 28, Inc.	Grappler Suture Anchor PCFD Tether System
2026-03-16	K254176	BAAT Medical Products B.V.	SINEFIX
2026-03-12	K251750	Trax Surgical, Inc.	Trax EX Anchor
2026-03-11	K253693	Riverpoint Medical, LLC	Strut Suture; No-Tie Button
2026-03-09	K260405	Arthrex, Inc.	FiberTape Button
2026-03-06	K253538	Theramicro	TeKBrace Knotless Anchor
2026-03-04	K254306	Aevumed, Inc.	Aevumed FENIX Suture Anchor
2026-03-02	K254229	Arthrex, Inc.	Arthrex Nano FiberTak Suture Anchor
2026-02-27	K253695	Riverpoint Medical, LLC	LigaMend
2026-01-29	K253763	Conmed Corporation	Y-Knotless Flex Anchors
2026-01-28	K260004	Aevumed, Inc.	Aevumed PROTEKT Suture Anchor
2026-01-06	K253618	Abanza Tecnomed S.L	QuadLock Fixation System
2025-12-30	K253895	Arthrex, Inc.	Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm