StageOne Select Hip Cement Spacer Molds— 510(k) K222760

Name: FDA 510(k) clearance K222760
Creator: U.S. Food and Drug Administration
Published: 2022-12-28

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K222760 for StageOne Select Hip Cement Spacer Molds, Substantially Equivalent on 2022-12-28. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MBB
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2022-09-13
Decision date: 2022-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBB

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K252443 — SpaceFix Shoulder Spacer2025-09-15
K242216 — GENTAFIX® (1, 3, 3MV)2024-12-18
K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds2024-11-20
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15
K213287 — StageOne Knee Cement Spacer Molds2022-09-02

More clearances from Biomet, Inc.

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K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07
K212435 — Comprehensive Humeral Fracture Positioning Sleeves2021-12-10

Adverse events under product code MBB

product code MBB

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.