STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT— 510(k) K080979

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2008-04-07

Decision date

2008-10-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K193038 — Comprehensive Shoulder System2020-10-28

Death

3

Injury

2,049

Total

2,052

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 K080979.