PLF · Bone Wedge · Chrysalis Intelligence

Device class

Class II

Regulation 888.3030

Total clearances

2020-02-25 → 2026-02-19

Last 12 months

Unique sponsors

Definition

What is Bone Wedge

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

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
Nvision Biomedical Technologies, Inc.	6	0	2024-11-08
Paragon 28, Inc.	1	0	2023-08-22
Auxano Medical, LLC	1	1	2025-09-25
Sinaptic Surgical	1	1	2025-10-17
Ames Medical Prosthetic Solutions, S.A.U.	1	0	2024-12-06
Restor3D, Inc.	1	0	2021-06-17
MiRus, LLC	1	1	2026-02-19

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
20691	CPT	—	Medium	Application of osteosynthesis device or bone plate; used in osteotomy procedures
27447	CPT	—	Medium	Tibial osteotomy with internal fixation; wedge placement for ankle/foot/tibial work

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-19	K252733	MiRus, LLC	ATLAS Expandable Osteotomy Wedge System
2025-10-17	K252254	Sinaptic Surgical	Osteotomy Wedge System
2025-09-25	K251791	Auxano Medical, LLC	Auxano® Wedge Fixation System
2024-12-06	K240461	Ames Medical Prosthetic Solutions, S.A.U.	OsteoSinter® EVANS and COTTON wedges and related accessories
2024-11-08	K243231	Nvision Biomedical Technologies	Trigon PEEK HA Wedges
2024-01-26	K234116	Nvision Biomedical Technologies	Trigon Trigon HA Stand-Alone Wedge Fixation System
2023-08-22	K231496	Paragon 28, Inc.	TITAN 3-D Wedge System
2022-12-01	K223226	Nvision Biomedical Technologies, Inc.	Trigon HA Stand-Alone Wedge Fixation System
2022-02-23	K220197	Nvision Biomedical Technologies, Inc.	Trigon HA Wedge Fixation System
2021-06-17	K201314	Restor3D, Inc.	Restor3d Utility Wedge
2020-12-21	K203445	Nvision Biomedical Technologies, Inc.	Trigon HA Stand-Alone Wedge Fixation System
2020-02-25	K193414	Nvision Biomedical Technologies, Inc.	Trigon HA Stand-Alone Wedge Fixation System