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Encore CLP Offset Total Hip System

by Encore Medical, Inc.

510(k) K052320

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052320 Date30 Dec 2005ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2605-2023 FDA Class II initiated 4 Aug 2023

    Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWA
FDA applicant
Encore Medical Corporation
Device Class
Class III
Regulation
21 CFR Part 888.3330
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Encore CLP Offset Total Hip System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. It features a metal, uncemented acetabular component with an offset design to address anatomical variations, providing stability and alignment in hip replacement procedures.

This system is intended for surgical use in orthopedic settings and is supplied sterile for single-use. It is classified as a Class III device under FDA regulations (21 CFR 888.3330) and has received FDA 510K clearance (K052320). Multiple component sizes and variants are available, as referenced by the listed FEI numbers, ensuring compatibility with various patient anatomies. Storage and handling must comply with sterile medical device protocols.

Other devices from Encore Medical, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the Encore CLP Offset Total Hip System designed to accommodate, and how does the offset design help?

    The Encore CLP Offset Total Hip System is designed for patients undergoing total hip arthroplasty who require anatomical adjustments due to variations in hip geometry. The offset design of the metal, uncemented acetabular component helps address these variations by improving stability and alignment, ensuring a better fit for diverse patient anatomies. This is particularly useful in cases where standard implants may not provide optimal positioning or function.

  • Is the Encore CLP Offset Total Hip System reusable or intended for single-use, and what does this mean for surgical planning?

    The Encore CLP Offset Total Hip System is supplied sterile for single-use only, meaning each component is intended to be used in one surgical procedure. This ensures patient safety by minimizing the risk of infection or contamination from reuse. Surgical planning must account for this, as unused components cannot be reprocessed or reused in subsequent cases.

  • How many component sizes and variants are available for the Encore CLP Offset Total Hip System, and why does this matter?

    The system includes multiple component sizes and variants, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096, etc.). This extensive range ensures compatibility with a wide variety of patient anatomies, allowing surgeons to select the most appropriate fit for individual cases. The availability of diverse sizes helps optimize implant performance and reduce the need for adjustments during surgery.

  • What storage and handling precautions should be taken with the Encore CLP Offset Total Hip System to maintain sterility?

    Since the Encore CLP Offset Total Hip System is supplied sterile, storage and handling must strictly comply with sterile medical device protocols. This includes keeping the components in their original packaging until use, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise sterility and patient safety.

  • What regulatory pathway was followed for FDA clearance of the Encore CLP Offset Total Hip System, and what does this mean for its use?

    The Encore CLP Offset Total Hip System received FDA 510K clearance (K052320) through a traditional review process, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously cleared device, ensuring it meets regulatory standards for use in total hip arthroplasty. The clearance confirms compliance with FDA requirements for Class III devices under 21 CFR 888.3330.