# K021178: SL-Plus Lateralized Stem

- Pathway: 510(k) (Special)
- Applicant: Plus Orthopedics
- Decided: May 14, 2002 after 29 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: 2 generations back to K932481 (1994). 2 ancestors in all.
126 later devices descend from it; 5 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001942: SL-Plus and SLR-Plus Stems, Plus Orthopedics (2000) Summary page 1.

## Most influential descendants
- K041950: Apex K2 Hip System (2004), 62 descendants of its own
- K090845: Apex Arc Hip Stem (2010), 58 descendants of its own
- K111193: Apex Arc Hip Stem (2011), 53 descendants of its own
- K113242: Apex Arc Hip Stem (2012), 52 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own

## Indications for use
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Source page: https://510kreport.com/device/K021178
Methodology: https://510kreport.com/methodology