ACCOLADE II HIP STEM— 510(k) K120578
Substantially EquivalentHowmedica Osteonics
FDA 510(k) clearance K120578 for ACCOLADE II HIP STEM, Substantially Equivalent on 2012-03-29. Applicant: Howmedica Osteonics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics
- 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
- Special
- Location
- Mahwah, NJ, 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 Howmedica Osteonics
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 K120578
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120578.
Data sourced from openFDA. This site is unofficial and independent of the FDA.