StageOne Select Cement Spacer Molds for Temporary Hip Replacement— 510(k) K161166

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBB

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2016-04-26

Decision date

2016-09-08

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-1638-2020 — BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.Class II·Terminated·Biomet, Inc.·20200226
• Z-1639-2020 — BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.Class II·Terminated·Biomet, Inc.·20200226
• Z-1640-2020 — BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.Class II·Terminated·Biomet, Inc.·20200226
• Z-1641-2020 — BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.Class II·Terminated·Biomet, Inc.·20200226
• Z-1642-2020 — BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.Class II·Terminated·Biomet, Inc.·20200226
• Z-1643-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.Class II·Terminated·Biomet, Inc.·20200226
• Z-1644-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.Class II·Terminated·Biomet, Inc.·20200226
• Z-1645-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.Class II·Terminated·Biomet, Inc.·20200226
• Z-1646-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.Class II·Terminated·Biomet, Inc.·20200226
• Z-1647-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.Class II·Terminated·Biomet, Inc.·20200226
• Z-1648-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.Class II·Terminated·Biomet, Inc.·20200226
• Z-1649-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.Class II·Terminated·Biomet, Inc.·20200226
• Z-1650-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.Class II·Terminated·Biomet, Inc.·20200226
• Z-1651-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.Class II·Terminated·Biomet, Inc.·20200226
• Z-1652-2020 — BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.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 K161166.