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510(k) K133811

Device
RESTORIS POROUS PARTIAL KNEE SYSTEM
Applicant
MAKO SURGICAL CORP.
510(k) number
K133811
Product code
NJD  
Decision
Substantially Equivalent (SESE)
Decision date
2014-07-08
Date received
2013-12-16
Regulation
888.3535
Classification name
Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TERRY POWELL
Address
575 Eighth Ave. Suite 1212 New York NY US 10018 10018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NJD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion2025-09-02
K242307ACHIEVE Partial Knee SystemIgnite Orthomotion2024-12-16
K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.2022-10-28
K190439Engage™ Partial Knee SystemEngage Uni, LLC2019-11-21

Legacy Summary#

summary

FDA Review#

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