EVOLUTION HIP SYSTEM— 510(k) K896105

Name: FDA 510(k) clearance K896105
Creator: U.S. Food and Drug Administration
Published: 1989-12-29

Substantially Equivalent for Some Indications

Dow Corning Wright

FDA 510(k) clearance K896105 for EVOLUTION HIP SYSTEM, Substantially Equivalent for Some Indications on 1989-12-29. Applicant: Dow Corning Wright. Device class: 2.

Clearance details

Applicant: Dow Corning Wright
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1989-10-20
Decision date: 1989-12-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWL

view all

K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253675 — OsteoRemedies Hip Spacer System2025-12-23
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

More clearances from Dow Corning Wright

view all

K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT1994-09-07
K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT1994-06-30
K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT1994-06-03
K932222 — SLT FEMORAL HEAD1994-05-27
K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT1994-02-16

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.