OLO · Orthopedic Stereotaxic Instrument

Device class

Class II

Regulation 882.4560

Total clearances

268

2020-01-17 → 2026-07-30

Last 12 months

Unique sponsors

108

Definition

What is Orthopedic Stereotaxic Instrument

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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
THINK Surgical, Inc.	14	4	2026-07-24
Brainlab AG	11	1	2025-09-12
Blue Belt Technologies, Inc.	10	2	2026-03-26
Mako Surgical Corp.	8	1	2026-02-25
Globus Medical, Inc.	8	1	2025-11-05
Stryker Leibinger GmbH & Co KG	8	2	2026-02-19
Medos International SARL	7	2	2026-05-26
Medtronic Navigation, Inc.	6	2	2026-02-12
Medtronic Sofamor Danek USA, Inc.	6	0	2023-05-26
Remex Medical Corp.	6	0	2025-05-29
Corelink, LLC	6	0	2023-10-27
Alphatec Spine, Inc.	6	1	2026-02-19
Ecential Robotics	5	1	2026-07-22
Blue Ortho	5	0	2024-01-26
Point Robotics MedTech, Inc.	5	2	2026-02-20
Orthosoft D/B/A Zimmer Cas	5	0	2023-11-16
Spineart SA	5	2	2026-07-29
Depuy Ireland UC	4	1	2026-06-25
Mazor Robotics , Ltd.	4	1	2025-09-11
Silony Medical GmbH	4	2	2026-06-26
7D Surgical, Inc.	4	0	2022-05-20
Proprio, Inc.	4	1	2025-12-15
Curexo, Inc.	4	1	2026-03-25
Orthosoft Inc (D/B/A Zimmer Cas)	3	0	2024-02-21
Providence Medical Technology, Inc.	3	1	2026-06-18

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
20999	CPT	—	Medium	Unlisted musculoskeletal surgery procedure; no standard CPT exists for stereotaxic orthopedic navigation guidance alone
64999	CPT	—	Low	Unlisted nervous system procedure; stereotaxic instruments more commonly paired with primary spine/joint CPT code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-30	K261410	Suite 201, National Innovation Centre	Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
2026-07-29	K261205	Spineart SA	SPINEART Navigation Instrument System
2026-07-24	K262121	SurGenTec, LLC	Ion-L Navigated Instruments
2026-07-24	K261024	THINK Surgical, Inc.	TMINI Miniature Robotic System
2026-07-22	K261113	Ecential Robotics	Op.n Spine Navigation and Robotic Guidance
2026-07-01	K261852	Ortoma AB	OTS Hip
2026-06-26	K253921	Silony Medical GmbH	VERTICALE® Navigation Instruments
2026-06-25	K260480	Depuy Ireland UC	VELYS Robotic-Assisted Solution
2026-06-20	K260369	LEM Surgical AG	Dynamis Robotic Surgical System
2026-06-18	K261665	Providence Medical Technology, Inc.	CORUS Navigation System-GN
2026-06-02	K260571	Life Spine, Inc.	SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
2026-05-29	K261060	Tyber Medical, LLC	Navigated LLIF Impactable Tracker
2026-05-26	K254157	Medos International SARL	CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
2026-05-22	K260329	SurGenTec, LLC	Ion-C Navigation Instruments
2026-05-21	K260582	Orthosoft Inc. (d/b/a) Zimmer CAS	ROSA® Shoulder System
2026-05-11	K252880	Pytheas Navigation Sas	Pytheas Your Guided Trajectory
2026-04-16	K260011	Foundation Surgical Group, Inc.	Foundation Surgical Navigated Lateral Disc Prep Instruments
2026-04-09	K254158	Spineart SA	SPINEART Navigation Instrument System
2026-03-27	K260240	Medos International SARL	SYMPHONY Navigation Ready Instruments
2026-03-26	K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI
2026-03-25	K252037	Curexo, Inc.	CUVIS-joint (CJ150)
2026-03-20	K253604	SurGenTec, LLC	TiLink-L Navigation Instruments
2026-03-18	K253444	MiRus, LLC	EUROPA Posterior Cervical Fusion Navigated Instruments
2026-03-17	K260546	K2m, Inc.	Q Pedicle Instruments
2026-03-03	K260010	THINK Surgical, Inc.	TMINI® Miniature Robotic System