DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION— 510(k) K980925

Name: FDA 510(k) clearance K980925
Creator: U.S. Food and Drug Administration
Published: 1998-12-16

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K980925 for DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION, Substantially Equivalent on 1998-12-16. 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: 1998-03-11
Decision date: 1998-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

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K983528 — MICRO DYNAMIC MESH1998-12-23
K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11
K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION1998-12-11

Adverse 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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.