Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments— 510(k) K253515
Substantially EquivalentBiomet Orthopedics, Inc.
FDA 510(k) clearance K253515 for Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments, Substantially Equivalent on 2026-08-24. Applicant: Biomet Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Orthopedics, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDI
view all- K253434 — OSSTM Orthopedic Salvage System
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- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
- K240418 — Stryker Orthopaedics Hip Systems Labeling Update
More clearances from Biomet Orthopedics, Inc.
view allAdverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.