Orthalign, Inc.
Orthalign, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Orthalign, Inc.
FDA recalls by Orthalign, Inc.
- Z-1629-2026 — Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
- Z-1630-2026 — Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Orthalign, Inc.
- K262253 — Lantern Knee Navigation Unit (406000-03); Lantern Hip Navigation Unit (502000-03)
- K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
- K242616 — Lantern® Hip
- K200892 — Harvey(R) Surgical Assistant
- K200642 — OrthAlign Plus System
- K172462 — OrthAlign Plus System
- K171780 — OrthAlign Plus System
- K163379 — KneeAlign 2 System
- K162962 — OrthAlign Plus System
- K153237 — OrthAlign Plus System
- K140331 — ORTHALIGN PLUS SYSTEM
- K130387 — ORTHOALIGN PLUS SYSTEM
- K103829 — KNEEALIGN SYSTEM
- K093998 — KNEEALIGN SYSTEM WITH REFERENCE SENSOR
- K091411 — KNEEALIGN SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.