Actis 1010-13-100

by Depuy (Ireland)

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	Number10603295380740 UDI-DI	Date13 Nov 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK150862	Date25 Sep 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10603295380740
FDA 510(k) database 510(k) number K150862

Recalls

1 recall · FDA

- Terminated Z-0650-2017 FDA Class II initiated 25 Oct 2016
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Actis
Generic name: Coated femoral stem prosthesis, one-piece
Model / Ref / Catalog: 1010-13-100, 101013100

Primary DI / UDI-DI: 10603295380740
510(k) Number: K150862
FDA product code: LPH, MEH, KWY, KWL
GMDN term: Coated femoral stem prosthesis, one-piece

Device class: Class II
Regulation number: 888.3358, 888.3353, 888.3390, 888.3360
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)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No