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510(k) K200665

VERASENSE for Stryker Triathlon by Orthosensor, Inc. — Product Code ONN

K200665 is an FDA 510(k) premarket notification submitted by Orthosensor, Inc. for the device "VERASENSE for Stryker Triathlon". The FDA issued a decision of Substantially Equivalent on April 12, 2020. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthosensor, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2020
Date Received
March 13, 2020
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 Orthosensor, Inc.

  • K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size (August 25, 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)
  • K150372 — VERASENSE Knee System (April 15, 2016)
  • K131767 — ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM (November 8, 2013)
  • K130380 — ORTHOSENSOR KNEE BALANCER (June 13, 2013)
  • K090474 — ORTHOREX INTRA-OPERATIVE LOAD SENSOR (October 19, 2009)

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)
  • K241298 — QUADSENSE (October 4, 2024)
  • 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)
  • 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