# K161610: EXPRT Revision Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Nov 9, 2016 after 152 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921308 (1994). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;, Encore Medical L.P. (2010) Summary page 4.
- K130099: Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019, Encore Medical L.P. (2013) Summary page 4.
- K050138: Modification to: Restoration Modular System, Howmedica Osteonics Corp. (2005) Summary page 4.

## Most influential descendants
- K163497: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt (2017), 0 descendants of its own

## Indications for use
Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Source page: https://510kreport.com/device/K161610
Methodology: https://510kreport.com/methodology