OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS— 510(k) K884398
Substantially Equivalent for Some IndicationsOsteonics Corp.
FDA 510(k) clearance K884398 for OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS, Substantially Equivalent for Some Indications on 1989-01-17. Applicant: Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Osteonics 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
- Allendale, NJ, US
Recent devices under product code JWH
view allMore clearances from Osteonics 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 K884398
K-number listed on FDA's recall record- Z-0873-2024 — SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
- Z-0874-2024 — SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884398.
Data sourced from openFDA. This site is unofficial and independent of the FDA.