# K052320: Encore CLP Offset Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical Corporation
- Decided: Dec 30, 2005 after 127 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 4, 2023 · Class II · Z-2605-2023: 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, 

## Indications for use
The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Encore CLP Offset Hip Stem is intended for Cementless Applications

Source page: https://510kreport.com/device/K052320
Methodology: https://510kreport.com/methodology