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.
Summary
Biomet Orthopedics filed the Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments under product code JDI: hip prosthesis, semi-constrained, metal/polymer, cemented. The record gives no model numbers.
Class II, 21 CFR 888.3350. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Biomet filed from Warsaw, Indiana. The decision came 290 calendar days after FDA received it (November 7, 2025 to August 24, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Biomet Orthopedics, Inc.
- Product code
- Product 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
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- 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.