AGC TOTAL KNEE PROSTHESIS— 510(k) K833921
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K833921 for AGC TOTAL KNEE PROSTHESIS, Substantially Equivalent on 1984-01-31. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, 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
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JWH
view allMore clearances from Biomet, 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 K833921
K-number listed on FDA's recall record- Z-0627-2018 — AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
- Z-0628-2018 — AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K833921.
Data sourced from openFDA. This site is unofficial and independent of the FDA.