Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial— 510(k) K142814
Substantially EquivalentBiomet Manufacturing, LLC
FDA 510(k) clearance K142814 for Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial, Substantially Equivalent on 2015-06-25. Applicant: Biomet Manufacturing, LLC. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing, LLC
- 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- K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- 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
More clearances from Biomet Manufacturing, LLC
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 →
Recalls naming K142814
K-number listed on FDA's recall record- Z-2231-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
- Z-2232-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
- Z-2233-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
- Z-2234-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
- Z-2235-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
- Z-2236-2019 — Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142814.
Data sourced from openFDA. This site is unofficial and independent of the FDA.