02.111.225

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10886982031426 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK081071	Date1 May 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10886982031426
FDA 510(k) database 510(k) number K081071

Recalls

1 recall · FDA

- Terminated Z-0014-2014 FDA Class II initiated 8 Mar 2013
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Orthopaedic bone bolt
Model / Ref / Catalog: 02.111.225, 02111225

Primary DI / UDI-DI: 10886982031426
510(k) Number: K081071
FDA product code: HWC
GMDN term: Orthopaedic bone bolt

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Synthes

68.134.011

Class II
Volt 68.134.111

Class II
Volt 68.134.200

Class II
68.045.017

Class II
68.045.020

Class II
68.045.019

Class II

See all devices from Synthes →

Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10)

Supplied sterile: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No