NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE— 510(k) K110054

Clearance details

Applicant

Zimmer Cas

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2011-01-07

Decision date

2011-03-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Montreal, CA

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• K141601 — IASSIST KNEE SYSTEM2014-09-11
• K131129 — CAS PSI SHOULDER2013-08-20

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0721-2022 — NavitrackER Kit A: Knee, Model Number 20-8000-000-07,Class II·Ongoing·Orthosoft, Inc. dba Zimmer CAS·20220107
• Z-1881-2017 — Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement componentsClass II·Terminated·Orthosoft, Inc. dba Zimmer CAS·20111006

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110054.