# K031165: Plus Orthopedics Cemented Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Jun 6, 2003 after 53 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952191 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 1.
- K991227: 8MM Forged Cemented Stem, Encore Orthopedics, Inc. (1999) Summary page 1.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1.
- K013352: Summit Cemented Hip Prosthesis, DePuy Orthopaedics, Inc. (2001)

## Most influential descendants
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The PLUS Orthopedics Cemented Hip Stern is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously faiIed hip arthropIasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Source page: https://510kreport.com/device/K031165
Methodology: https://510kreport.com/methodology