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FDA 510(k)

Restoris Multi-Compartmental Knee System

K-Number: K220930 · 2022-06-02

ApplicantMako Surgical Corp.
Decision Date2022-06-02
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Restoris Multi-Compartmental Knee System is a medical device manufactured by Mako Surgical Corp.. It received FDA 510(k) clearance on 2022-06-02 under approval number K220930. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restoris Multi-Compartmental Knee System?

Restoris Multi-Compartmental Knee System is a medical device that received FDA 510(k) clearance on 2022-06-02. It is manufactured by Mako Surgical Corp.. The 510(k) number is K220930.

When was Restoris Multi-Compartmental Knee System approved by the FDA?

Restoris Multi-Compartmental Knee System received FDA 510(k) clearance on 2022-06-02, under approval number K220930.

What company makes Restoris Multi-Compartmental Knee System?

Restoris Multi-Compartmental Knee System is manufactured by Mako Surgical Corp..

What is the FDA product code for Restoris Multi-Compartmental Knee System?

The FDA product code for Restoris Multi-Compartmental Knee System is HSX.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING NCT05252702 Aveir DR i2i Study COMPLETED

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Mako Surgical Corp.

K172301Mako Partial Knee Application K172219Mako Total Knee Application K170891Mako Partial Knee Application K170584Mako Partial Knee Application K170581Mako Total Knee Application K170593Mako Total Hip Application

View all 16 devices →

Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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