Restoris

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name: RESTORIS FDA UDI
Generic Name: Unicondylar knee prosthesis FDA UDI
Device Name: MCK Onlay Tibia Baseplate FDA UDI
Model / Reference: 180618 FDA UDI
Description: MCK Onlay Tibia Baseplate FDA UDI

Identifiers

Catalog Number: 180618 FDA UDI
Primary DI / UDI-DI: 00848486000813 FDA UDI
510(k) Number: K082172 FDA UDI
K090763 FDA UDI
K150307 FDA UDI
FDA Product Code: NPJ FDA UDI
HRY FDA UDI
KRR FDA UDI
HSX FDA UDI
GMDN Term: Unicondylar knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3530 FDA UDI
888.3540 FDA UDI
888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Unicondylar knee prosthesis

Restoris by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unicondylar knee prosthesis.

Engage Partial Knee System — Engage Uni, LLC · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
GENESIS II — Smith & Nephew, Inc. · Class II
OvertureTi — OVERTURE ORTHOPAEDICS · Class II
Arthrex® — Arthrex, Inc. · Class II

Cleared under the same submission

K082172 also covers:

K090763 also covers:

K150307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: MAKO Surgical Corp.

Sources (1)

FDA UDI 0961768c-0620-4cdd-b6d9-8a0d30b40825 36 fields · synced Jun 9, 2026