ENCORE CLP OFFSET TOTAL HIP SYSTEM— 510(k) K052320

Name: FDA 510(k) clearance K052320
Creator: U.S. Food and Drug Administration
Published: 2005-12-30

Substantially Equivalent

Encore Medical Corporation

FDA 510(k) clearance K052320 for ENCORE CLP OFFSET TOTAL HIP SYSTEM, Substantially Equivalent on 2005-12-30. Applicant: Encore Medical Corporation. Device class: 3.

Clearance details

Applicant: Encore Medical Corporation
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2005-08-25
Decision date: 2005-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

view all

K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
K121544 — DYNASTY BIOFOAM SHELL2012-07-30
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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 →

Recalls naming K052320

K-number listed on FDA's recall record

Z-2605-2023 — DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030Class II·Ongoing·Encore Medical, LP·20230804

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052320.

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