RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM— 510(k) K133039

Name: FDA 510(k) clearance K133039
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Substantially Equivalent

Mako Surgical Corporation

FDA 510(k) clearance K133039 for RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM, Substantially Equivalent on 2013-12-10. Applicant: Mako Surgical Corporation. Device class: 2.

Clearance details

Applicant: Mako Surgical Corporation
Product code: Code NPJ
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2013-09-26
Decision date: 2013-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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K150307 — RESTORIS Multicompartmental Knee System2015-03-10
K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM2009-12-16
K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM2009-12-15
K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM2009-06-17
K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS2007-06-26

More clearances from Mako Surgical Corporation

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K142530 — Partial Knee Application (PKA)2015-09-16
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM2014-11-13
K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM2012-06-06
K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM2012-03-01

Adverse events under product code NPJ

product code NPJ

Injury: 258
Total: 258

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.