RESTORIS Multicompartmental Knee System— 510(k) K150307

Name: FDA 510(k) clearance K150307
Creator: U.S. Food and Drug Administration
Published: 2015-03-10

Substantially Equivalent

Mako Surgical Corp.

FDA 510(k) clearance K150307 for RESTORIS Multicompartmental Knee System, Substantially Equivalent on 2015-03-10. Applicant: Mako Surgical Corp.. Device class: 2.

Clearance details

Applicant: Mako Surgical Corp.
Product code: Code NPJ
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2015-02-09
Decision date: 2015-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPJ

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K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM2013-12-10
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 Corp.

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K260222 — Mako Total Knee Application2026-02-25
K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer2025-04-25
K243751 — Mako Total Hip Application 5.02025-03-05
K242373 — Mako Shoulder Application (1.0)2024-11-07
K241011 — Mako Total Knee Application2024-06-11

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.