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510(k) K110054

NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE by Zimmer Cas — Product Code OLO

K110054 is an FDA 510(k) premarket notification submitted by Zimmer Cas for the device "NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE". The FDA issued a decision of Substantially Equivalent on March 24, 2011. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Zimmer Cas has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2011
Date Received
January 7, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by Zimmer Cas

  • K141601 — IASSIST KNEE SYSTEM (September 11, 2014)
  • K131129 — CAS PSI SHOULDER (August 20, 2013)

Other clearances for product code OLO

  • K262506 — Remex Spine Surgery Navigation - Universal Instruments (August 20, 2026)
  • K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registr (July 30, 2026)
  • K261205 — SPINEART Navigation Instrument System (July 29, 2026)
  • K261024 — TMINI Miniature Robotic System (July 24, 2026)
  • K262121 — Ion-L Navigated Instruments (July 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (July 22, 2026)
  • K261852 — OTS Hip (July 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)

FDA data resources