HWC · Screw, Fixation, Bone · Chrysalis Intelligence

Device class

Class II

Regulation 888.3040

Total clearances

150

2020-01-08 → 2026-08-12

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.	9	2	2026-06-25
Nextremity Solutions, Inc.	6	0	2022-11-04
OSSIO , Ltd.	6	1	2026-05-01
TriMed, Inc.	6	2	2026-08-12
Nvision Biomedical Technologies, Inc.	6	0	2025-04-02
MedShape, Inc.	4	1	2026-03-18
OsteoCentric Technologies	4	0	2024-10-09
Paragon 28, Inc.	4	0	2023-10-12
Tyber Medical, LLC	4	2	2026-04-03
Treace Medical Concepts, Inc.	4	1	2026-03-06
Vilex, LLC	3	0	2025-03-05
Skeletal Dynamics, Inc.	3	0	2023-04-28
Extremity Medical, LLC	3	1	2025-10-08
Innovate Orthopaedics, Ltd.	3	0	2025-01-31
Double Medical Technology, Inc.	3	0	2024-12-04
Stryker GmbH	3	0	2022-06-10
Medartis AG	3	1	2026-04-17
University of Utah, Department of Orthopaedics	2	1	2026-04-10
Curvafix, Inc.	2	1	2025-08-29
Medacta International S.A.	2	0	2022-02-03
Azurmeds, Inc.	2	0	2021-02-26
Medline Industries, LP	2	0	2024-08-02
Acumed, LLC	2	0	2023-06-09
In2bones USA, LLC	2	1	2026-05-30
Exsomed Corp.	2	0	2022-04-27

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	Application of fixation device; screw component of internal fixation
C1713	HCPCS	Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description	Low	Generic bone fixation screw component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-12	K262344	TriMed, Inc.	Large Compression Screws
2026-08-05	K253858	T.A.G. Medical Products Corporation, Ltd.	GFS - Sterile Screws and Top Hat
2026-07-22	K262075	Relja Innovations, LLC	Lapidus Screw Kit
2026-06-25	K260809	Arthrex, Inc.	Arthrex Sterile VAL and VAL KreuLock Compression Screw System
2026-06-05	K253108	Steps Ortho	VEOFIX Snap Off Screw
2026-05-30	K261154	In2Bones USA, LLC	CoLink® & CoLag® Non-Sterile Screws
2026-05-14	K261241	TriMed, Inc.	TriMed Compression Screws
2026-05-08	K254215	Arthrex, Inc.	Arthrex Beaming System
2026-05-01	K254077	OSSIO , Ltd.	OSSIOfiber® Threaded Trimmable Fixation Nail
2026-04-17	K260934	Medartis AG	TITAN Nail; APTUS K-Wire System
2026-04-10	K252699	University of Utah, Department of Orthopaedics	CoAptix S System
2026-04-03	K253042	Tyber Medical, LLC	Tyber Medical Trauma Screw
2026-03-18	K254110	MedShape, Inc.	DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
2026-03-06	K260361	Treace Medical Concepts, Inc.	Treace Medical Concepts (TMC) Screw Fixation System
2025-12-31	K252901	Tyber Medical, LLC	Tyber Medical Trauma Screw
2025-11-06	K251555	Pace Surgical	Ultra Compression Screw System
2025-10-10	K252312	Dev4	Eleganz IM Threaded Nail System (IM Threaded Nail System)
2025-10-08	K250536	Extremity Medical, LLC	MetaFore Small Screw System
2025-10-02	K252758	Orthonovis, Inc.	Cannulated Screw and Kirschner (K wire) System
2025-08-29	K252019	Curvafix, Inc.	CurvaFix Low Profile System
2025-08-27	K251382	Astra Orthomed, Inc.	Phoenix Sinus Tarsi Stent System
2025-08-15	K250867	Dunamis Medical, LLC	Dunamis Screw and Suture Locking System
2025-06-13	K250251	Dev4	Eleganz Fusion Screw System (Fusion Screw System)
2025-04-10	K243943	TriMed, Inc.	TriMed® Compression Screws
2025-04-02	K250613	Nvision Biomedical Technologies, Inc.	SnapHammer Hammertoe Correction System