ONN · Intraoperative Orthopedic Joint Assessment Aid

Device class

Class II

Regulation 882.4560

Total clearances

2020-04-01 → 2026-07-31

Last 12 months

Unique sponsors

Definition

What is Intraoperative Orthopedic Joint Assessment Aid

Measurement and interpretation of orthopedic joint information.

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
Orthosensor, Inc.	3	0	2020-08-25
Orthalign, Inc.	3	2	2026-07-31
Eventum Orthopaedics, Ltd.	2	1	2025-09-09
These Three Medical, LLC	1	0	2022-09-15

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
20610	CPT	—	Medium	Arthrocentesis, major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa); with ultrasound guidance, with permanent recording and reporting
77002	CPT	—	Medium	Fluoroscopic guidance for needle placement, radiological supervision and interpretation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K262253	Orthalign, Inc.	Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
2026-06-02	K253507	Orthalign, Inc.	Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
2025-09-09	K252524	Eventum Orthopaedics, Ltd.	Quadsense (Quadsense and Quadsense Pro)
2024-10-04	K241298	Eventum Orthopaedics, Ltd.	QUADSENSE
2024-10-03	K242616	Orthalign, Inc.	Lantern® Hip
2022-09-15	K220830	These Three Medical, LLC	TrueBalance Surgical System
2020-08-25	K200587	Orthosensor, Inc.	VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
2020-04-12	K200665	Orthosensor, Inc.	VERASENSE for Stryker Triathlon
2020-04-01	K193580	Orthosensor, Inc.	VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left