JDR · Staple, Fixation, Bone · Chrysalis Intelligence

Device class

Class II

Regulation 888.3030

Total clearances

2020-02-26 → 2026-08-06

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
Treace Medical Concepts	4	0	2024-12-26
Paragon 28, Inc.	3	1	2026-08-06
Medline Industries, LP	3	0	2025-04-11
MedShape, Inc.	2	0	2022-08-19
Arthrex, Inc.	2	0	2025-01-31
Novastep	1	0	2023-12-04
Wright Medical	1	0	2021-05-07
Medline Industries, Inc.	1	0	2021-04-22
Restor3D	1	0	2023-08-03
Stryker GmbH	1	0	2022-06-10
Tyber Medical, LLC	1	0	2022-10-20
Rmr Ortho, LLC	1	0	2024-01-12
Trax Surgical	1	0	2025-05-14
Medacta International S.A.	1	0	2021-04-12
Medartis, Inc.	1	0	2023-08-30
Neosteo	1	0	2020-02-28
Vilex, LLC	1	0	2023-08-11
Synthes (USA) Products, LLC	1	0	2020-02-26
Nextremity Solutions, Inc.	1	0	2022-03-22
Ortho Solutions UK , Ltd.	1	0	2024-02-23

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
20650	CPT	—	Medium	CPT for internal fixation of bone with staple/plate

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-06	K261121	Paragon 28, Inc.	Megalodon Dynamic Compression System
2025-05-14	K250712	Trax Surgical	Linkt Compression Staple System
2025-04-11	K243888	Medline Industries, LP	Medline UNITE® REFLEX® Hybrid Nitinol Implant System
2025-01-31	K243742	Arthrex, Inc.	Arthrex DynaNite Nitinol Staples
2024-12-26	K243658	Treace Medical Concepts	TMC Compression Implant System
2024-09-06	K242415	Treace Medical Concepts	TMC Compression Implant System
2024-02-23	K240212	Ortho Solutions UK , Ltd.	COGNiTiON Staple System
2024-01-12	K232990	Rmr Ortho, LLC	ATOMIC Nitinol Fixation System
2023-12-04	K230724	Novastep	arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
2023-10-19	K232905	Medline Industries, LP	Medline UNITE® REFLEX® Nitinol Staple Kit
2023-08-30	K232324	Medartis, Inc.	StealthFix Intraosseous Fixation System
2023-08-28	K232387	Treace Medical Concepts	Treace Medical Concepts (TMC) Compression Implant System
2023-08-11	K231493	Vilex, LLC	NITINEX Memory Compression Staple
2023-08-09	K231885	Medline Industries, LP	Medline UNITE® REFLEX® Nitinol Staple System
2023-08-03	K231458	Restor3D	Extremity Staple
2023-05-11	K230550	Paragon 28, Inc.	JAWS Nitinol Staple System
2023-02-16	K223056	Paragon 28, Inc.	JAWS Nitinol Staple System
2022-11-21	K222645	Treace Medical Concepts	Treace Medical Concepts (TMC) Implant Fixation System
2022-10-20	K221947	Tyber Medical, LLC	Tyber Medical Staple Fixation System (various)
2022-08-19	K220812	MedShape, Inc.	DynaClip® Bone Staple
2022-06-10	K210582	Stryker GmbH	EasyClip® and EasyClip® Xpress
2022-03-22	K220181	Nextremity Solutions, Inc.	StealthFix Intraosseous Fixation System
2021-05-07	K203832	Wright Medical	FuseForce Flex Dynamic Compression System
2021-04-22	K210482	Medline Industries, Inc.	Medline UNITE REFLEX Nitinol Staple System
2021-04-12	K210456	Medacta International S.A.	Ligament Staple