OUR · Sacroiliac Joint Fixation · Chrysalis Intelligence

Device class

Class II

Regulation 888.3040

Total clearances

2020-03-31 → 2026-04-08

Last 12 months

Unique sponsors

Definition

What is Sacroiliac Joint Fixation

sacroiliac joint fusion

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
SI-BONE, Inc.	12	2	2026-02-11
SurGenTec, LLC	7	0	2024-12-27
Orthofix, Inc.	4	0	2021-03-25
Spinal Simplicity, LLC	3	0	2025-06-03
Life Spine, Inc.	3	0	2024-07-29
Tenon Medical	3	1	2026-04-08
Aegis Spine	3	0	2023-01-20
Foundation Fusion Solutions, LLC (Dba Cornerloc)	2	0	2023-10-17
Alevio, LLC	2	0	2023-07-28
Cutting Edge Spine, LLC	2	0	2023-04-05
Promethean Restorative, LLC	2	0	2025-04-25
OsteoCentric Technologies	2	0	2023-09-21
L&K BIOMED Co., Ltd.	2	0	2024-02-23
Si-Technology, LLC	2	0	2025-06-06
Eminent Spine	2	1	2025-10-07
Camber Spine Technologies, LLC	2	0	2024-02-27
Deltacor GmbH	1	0	2024-01-19
Dio Medical Corporation	1	0	2022-10-13
Medacta International S.A.	1	0	2021-01-13
Ht Medical D.B.A. Xenix Medical	1	0	2023-08-15
Sail Fusion, LLC	1	0	2024-04-20
Biofusion Medical	1	0	2020-04-17
Ht Medical, LLC Dba Xenix Medical	1	0	2023-10-27
Choice Spine, LLC	1	0	2021-08-31
Corelink, LLC	1	0	2023-03-21

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
27280	CPT	—	High	Arthrodesis, sacroiliac joint; OUR is sacroiliac joint fixation device for fusion

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-08	K260477	Tenon Medical	CATAMARAN SI Joint Fusion System
2026-02-11	K253488	SI-BONE, Inc.	iFuse INTRA Ti Implant System
2026-01-29	K253611	Mcnicoll Surgical, Inc.	Falco Fusion System
2026-01-28	K252834	4Web Medical	Sacroiliac Joint Truss System (SJTS)
2025-11-20	K251365	Si Solutions, LLC	OptumSI Implant System
2025-10-22	K252322	Genesys Spine	SIros-X System
2025-10-09	K253094	SI-BONE, Inc.	iFuse Bedrock Granite Implant System
2025-10-07	K250894	Eminent Spine	Eminent Spine Posterior SI System
2025-07-29	K250647	Sivantage	SImmetry+ System
2025-07-09	K250247	Wenzel Spine, Inc.	panaSIa SI Fusion System
2025-06-26	K251395	Medtronic Sofamor Danek USA, Inc.	The Rialto SI Fusion System
2025-06-06	K251525	Si-Technology, LLC	SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
2025-06-06	K242431	Omnia Medical, LLC	Omnia Medical PsiF DNA System
2025-06-03	K250001	Spinal Simplicity, LLC	Patriot SI Implant System
2025-04-25	K251075	Promethean Restorative, LLC	DYNAMIS Implant System
2025-03-21	K250403	Tenon Medical	Catamaran SI Joint Fusion System
2025-03-14	K243838	Nexxt Spine	NEXXT MATRIXX® SI System
2025-02-28	K243565	Promethean Restorative, LLC	DYNAMIS SI Screw System
2024-12-27	K243835	SurGenTec, LLC	TiLink-P SI Joint Fusion System
2024-11-21	K242414	SurGenTec, LLC	TiLink-P Joint Fusion System
2024-08-21	K242141	SurGenTec, LLC	TiLink-P SI Joint Fusion System
2024-08-19	K241504	SI-BONE, Inc.	iFuse TORQ TNT Implant System
2024-08-13	K241813	Si-Technology, LLC	SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
2024-07-29	K241464	Life Spine, Inc.	ARx® SAI Implant System
2024-07-02	K241574	SI-BONE, Inc.	iFuse TORQ® Implant System