HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE— 510(k) K820030

Name: FDA 510(k) clearance K820030
Creator: U.S. Food and Drug Administration
Published: 1982-02-05

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K820030 for HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE, Substantially Equivalent on 1982-02-05. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1982-01-05
Decision date: 1982-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRY

view all

K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
K190633 — NanoOrtho NanoKnee® System2019-12-20
K152631 — MPO Total Knee Systems MR Labeling2016-03-23
K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

More clearances from Howmedica Corp.

view all

K983528 — MICRO DYNAMIC MESH1998-12-23
K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.