Solution System 1571-12-000

by Depuy Orthopaedics, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

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	Number10603295060734 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK953703	Date1 Feb 1996Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10603295060734
FDA 510(k) database 510(k) number K953703

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Solution System
Generic name: Coated femoral stem prosthesis, one-piece
Model / Ref / Catalog: 1571-12-000, 157112000

Primary DI / UDI-DI: 10603295060734
510(k) Number: K953703
FDA product code: LPH
GMDN term: Coated femoral stem prosthesis, one-piece

Device class: Class II
Regulation number: 888.3358
GUDID distribution status: In Commercial Distribution

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See all devices from Depuy Orthopaedics, Inc. →

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