Restoris

FDA UDI

Class II (US FDA UDI)

by MAKO Surgical Corp.

Identity

Trade Name: RESTORIS FDA UDI
Generic Name: Patella prosthesis trial FDA UDI
Device Name: MCK PATELLA DOME TRIAL (38mm) FDA UDI
Model / Reference: 170320-5 FDA UDI
Description: MCK PATELLA DOME TRIAL (38mm) FDA UDI

Identifiers

Catalog Number: 170320-5 FDA UDI
Primary DI / UDI-DI: 00848486003289 FDA UDI
510(k) Number: K082172 FDA UDI
K090763 FDA UDI
FDA Product Code: HRY FDA UDI
NPJ FDA UDI
HSX FDA UDI
KRR FDA UDI
GMDN Term: Patella prosthesis trial FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Patella prosthesis trial

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

Similar devices

Also classified as Patella prosthesis trial.

Unity Knee System — OMNIlife science, Inc. · Class I
BIOMET SERIES A — Biomet Orthopedics, Inc. · Class II
EXULT Knee Replacement System — Corentec Co., Ltd · Class II
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I

Cleared under the same submission

K082172 also covers:

K090763 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 5b498c5c-6193-4047-8256-80d50da90f3c 36 fields · synced Jun 9, 2026