DURACON PS LIPPED TIBIAL INSERT— 510(k) K012172
Substantially EquivalentHowmedica Osteonics
FDA 510(k) clearance K012172 for DURACON PS LIPPED TIBIAL INSERT, Substantially Equivalent on 2001-10-10. Applicant: Howmedica Osteonics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics
- 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
- Allendale, NJ, US
Recent devices under product code JWH
view allMore clearances from Howmedica Osteonics
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 K012172
K-number listed on FDA's recall record- Z-0923-2024 — PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
- Z-0924-2024 — PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012172.
Data sourced from openFDA. This site is unofficial and independent of the FDA.