MAI · Fastener, Fixation, Biodegradable, Soft Tissue

Device class

Class II

Regulation 888.3030

Total clearances

2020-01-15 → 2026-08-07

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3030

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.	13	2	2026-08-07
Acuitive Technologies, Inc.	5	0	2023-02-14
OSSIO , Ltd.	5	1	2026-02-24
Osteonic Co., Ltd.	4	0	2024-12-03
Aju Pharm Co., Ltd.	4	0	2023-06-09
Depuy Mitek	3	0	2025-02-05
Nanofiber Solutions, LLC	3	0	2024-07-29
Conmed Corporation	2	1	2025-10-15
Stryker Endoscopy	2	0	2025-05-23
Surgical Fusion Technologies GmbH	2	1	2026-03-27
Science & Bio Materials (S.B.M.) Sas	1	0	2023-07-26
Biocomposites, Ltd.	1	1	2026-02-17
Parcus Medical	1	0	2023-09-18
B-One Ortho, Corp.	1	0	2021-11-04
Embody, Inc.	1	0	2022-04-08
Teknimed	1	0	2023-05-12
Medacta International S.A.	1	0	2021-02-22
Smith & Nephew, Inc.	1	0	2020-03-18

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
20692	CPT	—	Medium	CPT code for removal of implant material; soft tissue implant or other prosthetic material, insertion/removal billed separately
99070	CPT	—	Medium	CPT code for supplies and materials when biodegradable fastener not otherwise specified

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K262357	Arthrex, Inc.	Arthrex Bioabsorbable PushLock Suture Anchors
2026-05-28	K253931	Arthrex, Inc.	Arthrex Bioabsorbable PushLock Suture Anchors
2026-03-27	K260294	Surgical Fusion Technologies GmbH	SF Push-in Anchor
2026-02-24	K254055	OSSIO , Ltd.	OSSIOfiber® Suture Anchor
2026-02-17	K251680	Biocomposites, Ltd.	Biosteon® Screw
2025-10-15	K252946	Conmed Corporation	BioBrace® Extra-Articular Ligament Augmentation Kit
2025-08-19	K252022	OSSIO , Ltd.	OSSIOfiber® Interference Screw
2025-05-27	K251309	OSSIO , Ltd.	OSSIOfiber® Suture Anchor
2025-05-23	K250544	Stryker Endoscopy	Knotilus+ Biocomposite Knotless Anchor
2025-05-21	K250528	Stryker Endoscopy	Stryker AlphaVent Knotless SP Biocomposite Anchor
2025-04-03	K243760	OSSIO , Ltd.	OSSIOfiber® Suture Anchor 2.5-3.5 mm
2025-03-14	K250526	Arthrex, Inc.	Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
2025-02-05	K243790	Depuy Mitek	GRYPHON X Anchor; HEALIX TRANSTEND Anchor
2024-12-03	K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
2024-09-11	K241010	Depuy Mitek	HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
2024-07-29	K241912	Nanofiber Solutions, LLC	BIOCHARGE
2024-06-04	K233971	Arthrex, Inc.	Arthrex AlloSync PushLock Suture Anchor
2024-04-01	K240288	Surgical Fusion Technologies GmbH	SF Push- in Anchor
2024-03-15	K240441	Depuy Mitek	MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
2024-03-05	K240090	Conmed Corporation	Argo Knotless GENESYS Anchor
2023-09-18	K232513	Parcus Medical	X-Twist Biocomposite Suture Anchor
2023-07-26	K231787	Science & Bio Materials (S.B.M.) Sas	ecoFIX®
2023-07-05	K231641	Nanofiber Solutions, LLC	Rotium Bioresorbable Wick
2023-06-09	K230892	Aju Pharm Co., Ltd.	Fixone Biocomposite Anchor
2023-05-31	K231326	Osteonic Co., Ltd.	Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)