PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT— 510(k) K894403
Substantially Equivalent for Some IndicationsHowmedica Corp.
FDA 510(k) clearance K894403 for PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT, Substantially Equivalent for Some Indications on 1990-02-02. 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 for Some Indications
- 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 K894403
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 K894403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.