HUMELOCK CEMENTED SHOULDER PROSTHESIS— 510(k) K111097

Clearance details

Applicant

Fx Solutions

Product code

Code HSD

Device class

Class 2

Regulation

21 CFR 888.3690

Advisory panel

Orthopedic

Date received

2011-04-20

Decision date

2011-11-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Viriat, FR

• K233260 — Univers Revers CA Head and Adapter2024-02-12
• K221232 — Univers Revers Humeral Cup Implant2022-05-19
• K191433 — AGILON® XO Shoulder Replacement System2020-11-12
• K193122 — Biocore9 Humeral Resurfacing System2020-05-15
• K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

• K163669 — Humeris Shoulder2017-05-17
• K162455 — Humelock Reversed Shoulder2017-01-17
• K150488 — Humelock II Reversible Shoulder System2015-11-13
• K143721 — PRCT22015-08-27
• K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM2014-07-28

Injury

3,425

Malfunction

531

Total

3,956

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2468-2018 — Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.Class II·Terminated·Fx Solutions·20180604
• Z-2469-2018 — Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.Class II·Terminated·Fx Solutions·20180604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111097.