VANGUARD PATELLA COMPONENTS— 510(k) K040770
Substantially EquivalentBiomet Manufacturing, Inc.
FDA 510(k) clearance K040770 for VANGUARD PATELLA COMPONENTS, Substantially Equivalent on 2004-04-22. Applicant: Biomet Manufacturing, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing, Inc.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code JWH
view allMore clearances from Biomet Manufacturing, Inc.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K040770
K-number listed on FDA's recall record- Z-2154-2020 — Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
- Z-0937-2019 — Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
- Z-1861-2017 — various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040770.
Data sourced from openFDA. This site is unofficial and independent of the FDA.