SBF · Orthopedic Augmented Reality · Chrysalis Intelligence

Device class

Class II

Regulation 882.4560

Total clearances

2020-07-10 → 2026-07-31

Last 12 months

Unique sponsors

Definition

What is Orthopedic Augmented Reality

An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.4560

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
Medacta International S.A.	10	2	2026-01-09
Augmedics, Ltd.	6	2	2026-07-31
Pixee Medical	5	0	2025-03-20
Mr Surgical Solutions, LLC	3	1	2025-09-10
Surgical Theater, Inc.	3	1	2025-09-29
Orthosoft Inc (D/B/A Zimmer Cas)	2	0	2023-06-13
Surgalign Spine Technologies	2	0	2023-08-31
Taiwan Main Orthopaedic Biotechnology Co., Ltd.	2	0	2024-10-30
Onpoint Surgical, Inc.	2	0	2024-08-19
Kico Knee Innovation Company Pty, Ltd.	2	0	2025-03-21
Polarisar, Inc.	1	0	2023-11-02
Globus Medical, Inc.	1	0	2025-07-08
Medacta Inernational SA	1	0	2020-07-10
Brainlab AG	1	0	2025-05-16
Pixee Medical S.A.S.	1	1	2026-04-24

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
20985	CPT	—	Medium	CPT for computer-assisted surgical navigation for orthopedic procedures, applicable to AR guidance

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K261854	Augmedics, Ltd.	xvision Spine system
2026-04-24	K253805	Pixee Medical S.A.S.	Knee+
2026-01-09	K252847	Medacta International S.A.	NextAR Hip Platform
2025-10-03	K251639	Augmedics, Ltd.	xvision Spine system
2025-09-29	K252054	Surgical Theater, Inc.	SpineAR SNAP (SyncAR Spine)
2025-09-10	K252530	Mr Surgical Solutions, LLC	OptiVu Shoulder
2025-09-04	K251737	Medacta International S.A.	NextAR(TM) Shoulder Platform
2025-08-08	K252170	Mr Surgical Solutions, LLC	OptiVu Shoulder
2025-07-31	K250477	Medacta International S.A.	NextAR(TM) Spine
2025-07-09	K250108	Mr Surgical Solutions, LLC	OptiVu Shoulder
2025-07-08	K241525	Globus Medical, Inc.	ExcelsiusXR
2025-05-16	K242569	Brainlab AG	Mixed Reality Spine Navigation
2025-03-21	K243980	Kico Knee Innovation Company Pty Limited	ARVIS Surgical Navigation System
2025-03-20	K243975	Pixee Medical	Knee+
2025-03-13	K250255	Augmedics, Ltd.	xvision Spine system
2025-01-13	K243950	Kico Knee Innovation Company Pty, Ltd.	ARVIS® Shoulder
2024-12-24	K243623	Surgical Theater, Inc.	SpineAR SNAP (SyncAR Spine)
2024-10-30	K242271	Taiwan Main Orthopaedic Biotechnology Co., Ltd.	Caduceus S
2024-10-16	K241481	Augmedics, Ltd.	xvision Spine System
2024-08-19	K241870	Onpoint Surgical, Inc.	OnPoint Augmented Reality Spine System
2024-04-24	K233172	Medacta International S.A.	NextAR Spine Platform
2024-03-08	K233899	Pixee Medical	Knee+
2023-11-02	K232176	Polarisar, Inc.	STELLAR Knee
2023-10-29	K232280	Medacta International S.A.	NextAR TSA Platform
2023-09-08	K231284	Onpoint Surgical, Inc.	OnPoint Augmented Reality Spine System