HTY · Product Code · Chrysalis Intelligence

Device class

—

Regulation —

Total clearances

2020-03-06 → 2025-12-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

—

Review panel

—

Regulation number

—

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
OSSIO , Ltd.	5	0	2023-12-01
Nvision Biomedical Technologies, Inc.	2	1	2025-09-19
OrthoPediatrics Corp.	2	0	2025-06-24
Skeletal Dynamics, Inc.	1	0	2021-09-30
Toetal Solutions	1	1	2025-12-29
Intelivation	1	0	2023-09-14
In2bones USA, LLC	1	0	2021-05-04
4Web Medical, Inc.	1	0	2022-09-06
AIRS, Inc.	1	0	2025-08-01
Biomet, Inc.	1	0	2024-05-22
Tyber Medical, LLC	1	0	2023-07-06
Restor3D	1	0	2022-01-04
Pacific Instruments	1	0	2022-02-17
Armis Biopharma, Inc.	1	0	2020-11-17
Stryker GmbH	1	0	2020-08-05
Arthrex, Inc.	1	0	2020-06-29
Lima Corporate S.P.A.	1	0	2021-02-05
Xiros, Ltd.	1	0	2022-07-22
Electro-Spec, Inc.	1	0	2023-08-14

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; pin often used in external fixation
C1713	HCPCS	Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description	Low	Generic bone fixation component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-12-29	K253325	Toetal Solutions	ZipToe Hammertoe Fusion System
2025-09-19	K252657	Nvision Biomedical Technologies, Inc.	Impact PEEK Union Nail System
2025-08-01	K250315	AIRS, Inc.	RONAVIS FX (FX-001)
2025-06-24	K251362	OrthoPediatrics Corp.	PediFlex Flexible Nail System
2025-06-11	K250646	Nvision Biomedical Technologies	Impact PEEK Union Nail System
2024-05-22	K241014	Biomet, Inc.	Biomet Kirschner Wires (K-Wires)
2023-12-01	K231272	OSSIO , Ltd.	OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
2023-09-14	K231147	Intelivation	Hammerdesis Interphalangeal Fusion System
2023-09-13	K230750	OSSIO , Ltd.	OSSIOfiber® Cannulated Trimmable Fixation Nail
2023-08-14	K231905	Electro-Spec, Inc.	Electro-Spec Steri-Caps
2023-07-06	K231339	Tyber Medical, LLC	Tyber Medical Pin and Wire System (various)
2022-09-06	K221283	4Web Medical, Inc.	Hammertoe Truss System (HTS)
2022-07-22	K220906	Xiros, Ltd.	SECURE-LOCK
2022-02-17	K213982	Pacific Instruments	Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
2022-01-04	K211789	Restor3D	restor3d Pin Implants
2021-09-30	K211439	Skeletal Dynamics, Inc.	Small Bone Nailing System
2021-05-04	K203698	In2bones USA, LLC	CoLink Sfx Implant System
2021-02-05	K203475	Lima Corporate S.P.A.	LimaCorporate Kirschner Wire
2021-01-29	K201838	OrthoPediatrics Corp.	PediFlex Flexible Nail System
2021-01-06	K203465	OSSIO , Ltd.	OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
2020-11-17	K202777	Armis Biopharma, Inc.	VeriFixx Small Bone Implant
2020-10-16	K201803	OSSIO , Ltd.	OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant
2020-08-05	K201715	Stryker GmbH	Smart Toe II, X Fuse
2020-06-29	K200068	Arthrex, Inc.	Arthrex DynaNite K-Wire
2020-03-06	K190652	OSSIO , Ltd.	OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant

HTY · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances