IASSIST KNEE SYSTEM— 510(k) K141601

Name: FDA 510(k) clearance K141601
Creator: U.S. Food and Drug Administration
Published: 2014-09-11

Substantially Equivalent

Zimmer Cas

FDA 510(k) clearance K141601 for IASSIST KNEE SYSTEM, Substantially Equivalent on 2014-09-11. Applicant: Zimmer Cas. Device class: 2.

Clearance details

Applicant: Zimmer Cas
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2014-06-16
Decision date: 2014-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

view all

K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

More clearances from Zimmer Cas

view all

K131129 — CAS PSI SHOULDER2013-08-20
K110054 — NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE2011-03-24

Adverse events under product code OLO

product code OLO

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.