DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS— 510(k) K915512
Substantially Equivalent for Some IndicationsPfizer Hospital Products Group, Inc.
FDA 510(k) clearance K915512 for DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS, Substantially Equivalent for Some Indications on 1992-08-18. Applicant: Pfizer Hospital Products Group, Inc.. Device class: 2.
Clearance details
- Applicant
- Pfizer Hospital Products Group, Inc.
- 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 Pfizer Hospital Products Group, 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 K915512
K-number listed on FDA's recall record- Z-0916-2024 — DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
- Z-0917-2024 — DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
- Z-0918-2024 — DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K915512.
Data sourced from openFDA. This site is unofficial and independent of the FDA.