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Restoris 160115

by MAKO Surgical Corp.

Restoris 160115 is a Class II device made by MAKO Surgical Corp., cleared under FDA 510(k) K090763 on 17 Jun 2009 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00848486019983), active as of 23 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848486019983 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090763 Date17 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090763 decided 17 Jun 2009 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00848486019983 listed 24 Sep 2016 Listed

Recalls

5 recalls · 2 ongoing · FDA

    • Ongoing Z-1386-2023 FDA Class II initiated 10 Mar 2023

    Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    • Ongoing Z-1385-2023 FDA Class II initiated 10 Mar 2023

    Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    • Terminated Z-2051-2018 FDA Class II initiated 19 Jan 2018

    Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

    • Terminated Z-1031-2016 FDA Class II initiated 15 Jan 2016

    Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.

    • Terminated Z-1132-2014 FDA Class II initiated 9 Jan 2014

    The product may be mislabeled and could result in the incorrect implant being used.

Timeline

8 dated events

  1. Cleared FDA 510(k) K082172
  2. Cleared FDA 510(k) K090763
  3. Recall initiated FDA recalls Z-1132-2014
  4. Recall initiated FDA recalls Z-1031-2016
  5. Listed FDA GUDID 00848486019983
  6. Recall initiated FDA recalls Z-2051-2018
  7. Recall initiated FDA recalls Z-1386-2023
  8. Recall initiated FDA recalls Z-1385-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Restoris
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
160115
Primary DI / UDI-DI
00848486019983
510(k) Number
FDA product code
HRY, HSX, KRR, NPJ
GMDN term
Surgical implant template, reusable
Device class
Class II
Regulation number
888.3530, 888.3520, 888.3540, 888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K082172)

and 8 more cleared under K082172

Cleared under the same submission (K090763)

and 8 more cleared under K090763

Similar devices in this category

Other devices filed under Surgical implant template, reusable.

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)