HOWMEDICA PCA COLLARED FEMORAL STEM— 510(k) K873458

Name: FDA 510(k) clearance K873458
Creator: U.S. Food and Drug Administration
Published: 1987-09-23

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K873458 for HOWMEDICA PCA COLLARED FEMORAL STEM, Substantially Equivalent for Some Indications on 1987-09-23. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1987-08-28
Decision date: 1987-09-23
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDG

view all

K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07
K193546 — Distal Centralizers2020-09-25
K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10

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 JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.