DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES— 510(k) K050210

Name: FDA 510(k) clearance K050210
Creator: U.S. Food and Drug Administration
Published: 2005-07-19

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K050210 for DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES, Substantially Equivalent on 2005-07-19. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2005-01-28
Decision date: 2005-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

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

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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 →

Recalls naming K050210

K-number listed on FDA's recall record

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 K050210.

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