Home / 510(k) Clearances / K241298

510(k) K241298

QUADSENSE by Eventum Orthopaedics, Ltd. — Product Code ONN

K241298 is an FDA 510(k) premarket notification submitted by Eventum Orthopaedics, Ltd. for the device "QUADSENSE". The FDA issued a decision of Substantially Equivalent on October 4, 2024. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Eventum Orthopaedics, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2024
Date Received
May 8, 2024
Clearance Type
Traditional
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 Eventum Orthopaedics, Ltd.

  • K252524 — Quadsense (Quadsense and Quadsense Pro) (September 9, 2025)

Other clearances for product code ONN

  • K262253 — Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (July 31, 2026)
  • K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (June 2, 2026)
  • K252524 — Quadsense (Quadsense and Quadsense Pro) (September 9, 2025)
  • K242616 — Lantern® Hip (October 3, 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)

FDA data resources