Restoris Esyntial 180741-5

by MAKO Surgical Corp.

Restoris Esyntial 180741-5 is a Class II device made by MAKO Surgical Corp., cleared under FDA 510(k) K133039 on 10 Dec 2013 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00848486015190), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00848486015190 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK133039	Date10 Dec 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00848486015190
FDA 510(k) database 510(k) number K133039

Across registries

2 registries list this device

FDA 510(k) K133039 decided 10 Dec 2013 Active
FDA GUDID UDI-DI 00848486015190 listed 24 Sep 2015 Listed

Timeline

2 dated events

10 Dec 2013 Cleared FDA 510(k) K133039
24 Sep 2015 Listed FDA GUDID 00848486015190

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Restoris Esyntial
Generic name: Unicondylar knee prosthesis
Model / Ref / Catalog: 180741-5

Primary DI / UDI-DI: 00848486015190
510(k) Number: K133039
FDA product code: KRR, NPJ, HRY, HSX, OIY
GMDN term: Unicondylar knee prosthesis

Device class: Class II
Regulation number: 888.3540, 888.3560, 888.3530, 888.3520
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)