ONCOLOGY SALVAGE SYSTEM— 510(k) K002757

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

2000-09-05

Decision date

2000-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
• K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems2024-10-21
• K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component2024-08-02

• 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
• K213287 — StageOne Knee Cement Spacer Molds2022-09-02

Death

65

Injury

12,943

Malfunction

1,681

Total

14,689

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-0623-2021 — OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.Class II·Terminated·Biomet, Inc.·20201125
• Z-2147-2020 — Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesisClass II·Terminated·Biomet, Inc.·20200417
• Z-0590-2019 — Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394Class II·Terminated·Zimmer Biomet, Inc.·20181010
• Z-0303-2018 — OSS CEMENTED IM STEM 12X150, model # 150366Class II·Terminated·Zimmer Biomet, Inc.·20170605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002757.