DURATION STABILIZED UHMWPE KNEE COMPONENTS— 510(k) K972863
Substantially EquivalentHowmedica Corp.
FDA 510(k) clearance K972863 for DURATION STABILIZED UHMWPE KNEE COMPONENTS, Substantially Equivalent on 1997-10-29. Applicant: Howmedica Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Corp.
- 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
- Rutherford, NJ, US
Recent devices under product code JWH
view allMore clearances from Howmedica Corp.
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 K972863
K-number listed on FDA's recall record- Z-0919-2024 — DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
- Z-0920-2024 — DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
- Z-0921-2024 — DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
- Z-0922-2024 — DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972863.
Data sourced from openFDA. This site is unofficial and independent of the FDA.