StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis— 510(k) K161273

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBB

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2016-05-05

Decision date

2017-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• 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
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K213287 — StageOne Knee Cement Spacer Molds2022-09-02
• K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07

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 →

• Z-1662-2020 — BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.Class II·Terminated·Biomet, Inc.·20200226
• Z-1663-2020 — BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.Class II·Terminated·Biomet, Inc.·20200226
• Z-1664-2020 — BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.Class II·Terminated·Biomet, Inc.·20200226
• Z-1665-2020 — BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.Class II·Terminated·Biomet, Inc.·20200226
• Z-1666-2020 — BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.Class II·Terminated·Biomet, Inc.·20200226
• Z-1667-2020 — BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.Class II·Terminated·Biomet, Inc.·20200226
• Z-1668-2020 — BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.Class II·Terminated·Biomet, Inc.·20200226
• Z-1669-2020 — BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.Class II·Terminated·Biomet, Inc.·20200226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161273.