Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds— 510(k) K240856

Clearance details

Applicant

Osartis GmbH

Product code

Code MBB

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2024-03-28

Decision date

2024-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Münster, DE

• K252443 — SpaceFix Shoulder Spacer2025-09-15
• K242216 — GENTAFIX® (1, 3, 3MV)2024-12-18
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15
• K213287 — StageOne Knee Cement Spacer Molds2022-09-02

• K202458 — BonOs Inject, Pedicle screw kits, Cement pusher2021-05-18
• K210120 — BonOs HV, BonOs MV, BonOs LV2021-03-19
• K210125 — BonOs HV Genta, BonOs MV Genta, BonOs LV Genta2021-03-19
• K192394 — Hi-Fatigue Bone Cement2019-12-02
• K192379 — Hi-Fatigue G Bone Cement2019-11-27

Death

27

Injury

1,412

Malfunction

551

Total

1,990

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 →