RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM— 510(k) K090763

Name: FDA 510(k) clearance K090763
Creator: U.S. Food and Drug Administration
Published: 2009-06-17

Substantially Equivalent

Mako Surgical Corporation

FDA 510(k) clearance K090763 for RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM, Substantially Equivalent on 2009-06-17. 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: 2009-03-23
Decision date: 2009-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPJ

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K150307 — RESTORIS Multicompartmental Knee System2015-03-10
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
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 →

Recalls naming K090763

K-number listed on FDA's recall record

Z-1385-2023 — stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedureClass II·Ongoing·Howmedica Osteonics Corp.·20230310
Z-1386-2023 — stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedureClass II·Ongoing·Howmedica Osteonics Corp.·20230310
Z-2051-2018 — Restoris MCK Onlay Insert Extractor.Class II·Terminated·Mako Surgical Corporation·20180119
Z-1031-2016 — Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.Class II·Terminated·Mako Surgical Corporation·20160115
Z-1132-2014 — Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.Class II·Terminated·Mako Surgical Corporation·20140109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090763.

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