RESTORIS POROUS PARTIAL KNEE SYSTEM— 510(k) K150410

Name: FDA 510(k) clearance K150410
Creator: U.S. Food and Drug Administration
Published: 2015-03-20

Substantially Equivalent

Mako Surgical Corporation

FDA 510(k) clearance K150410 for RESTORIS POROUS PARTIAL KNEE SYSTEM, Substantially Equivalent on 2015-03-20. Applicant: Mako Surgical Corporation. Device class: 2.

Clearance details

Applicant: Mako Surgical Corporation
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 2015-02-18
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

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K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K190633 — NanoOrtho NanoKnee® System2019-12-20
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28
K131167 — UNIVATION2013-10-17

More clearances from Mako Surgical Corporation

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K142530 — Partial Knee Application (PKA)2015-09-16
K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM2014-11-13
K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM2013-12-10
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 HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.