Chrysalis Intelligence · Sponsors · Orthalign, Inc.

Orthalign, Inc.

Aliso Viejo, CA, US · 5 510(k) clearances · 2 recalls

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Total clearances

5

2020-04-10 → 2026-07-31

Last 12 months

2

Product codes

2

Most recent

2026-07-31

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
ONN	Intraoperative Orthopedic Joint Assessment Aid	Class II	Neurology	3	2026-07-31
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	2	2020-06-18

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2026-02-10

Date	Severity	Status	Recall #	Product	Code	Reason
2026-02-10	Class II	Ongoing	Z-1630-2026	Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System	—	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
2026-02-10	Class II	Ongoing	Z-1629-2026	Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System	—	Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2026-07-31	K262253	Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)	ONN	Class II	Neurology
2026-06-02	K253507	Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee	ONN	Class II	Neurology
2024-10-03	K242616	Lantern® Hip	ONN	Class II	Neurology
2020-06-18	K200892	Harvey(R) Surgical Assistant	OLO	Class II	Neurology
2020-04-10	K200642	OrthAlign Plus System	OLO	Class II	Neurology