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510(k) K242616

Lantern® Hip by Orthalign, Inc. — Product Code ONN

K242616 is an FDA 510(k) premarket notification submitted by Orthalign, Inc. for the device "Lantern® Hip". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthalign, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2024
Date Received
September 3, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Orthopedic Joint Assessment Aid
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Measurement and interpretation of orthopedic joint information.

Other clearances by Orthalign, Inc.

  • K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (June 2, 2026)
  • K200892 — Harvey(R) Surgical Assistant (June 18, 2020)
  • K200642 — OrthAlign Plus System (April 10, 2020)
  • K172462 — OrthAlign Plus System (November 22, 2017)
  • K171780 — OrthAlign Plus System (July 11, 2017)
  • K163379 — KneeAlign 2 System (March 2, 2017)
  • K162962 — OrthAlign Plus System (January 23, 2017)
  • K153237 — OrthAlign Plus System (March 1, 2016)
  • K140331 — ORTHALIGN PLUS SYSTEM (June 10, 2014)
  • K130387 — ORTHOALIGN PLUS SYSTEM (November 8, 2013)

Other clearances for product code ONN

  • K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (June 2, 2026)
  • K252524 — Quadsense (Quadsense and Quadsense Pro) (September 9, 2025)
  • K241298 — QUADSENSE (October 4, 2024)
  • K220830 — TrueBalance™ Surgical System (September 15, 2022)
  • K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size (August 25, 2020)
  • K200665 — VERASENSE for Stryker Triathlon (April 12, 2020)
  • K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet (April 1, 2020)
  • K180459 — VERASENSE for Zimmer Biomet Persona (June 7, 2018)
  • K162237 — XO1 Knee Balancing System (April 25, 2017)
  • K150372 — VERASENSE Knee System (April 15, 2016)

FDA data resources