DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC— 510(k) K920034

Name: FDA 510(k) clearance K920034
Creator: U.S. Food and Drug Administration
Published: 1992-03-18

Substantially Equivalent

Pfizer Hospital Products Group, Inc.

FDA 510(k) clearance K920034 for DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC, Substantially Equivalent on 1992-03-18. Applicant: Pfizer Hospital Products Group, Inc.. Device class: 2.

Clearance details

Applicant: Pfizer Hospital Products Group, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1992-01-06
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Pfizer Hospital Products Group, Inc.

view all

K930156 — MEGA PLUS SUPER LAG SCREW1994-02-22
K915512 — DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS1992-08-18
K920831 — PCA TOTAL HIP SYSTEM (CEMENTLESS USE)1992-06-10
K915184 — HOWMEDICA ALUMINA FEMORAL HEAD1992-01-31
K911656 — PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST1991-08-13

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.