Titan Modular Total Shoulder System

by Ascension Orthopedic 510(k)

Active United States

510(k) K112438

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK112438	Date11 Apr 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K112438
FDA Product Code: KWS

Device Class: Class II
Regulation: 21 CFR Part 888.3660
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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