# K032548: IP-XS Compression Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: Sep 10, 2003 after 23 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K913949 (1992). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003)
- (no number) SST Small Bone Locking Nail: named in the summary without a submission number

## Most influential descendants
- K081356: Olecranail Intramedullary Fixation System (2008), 2 descendants of its own
- K090091: Olecranail Intramedullary Fixation System (2009), 1 descendant of its own
- K161371: Sonoma Fifth Metatarsal Repair System (2017), 0 descendants of its own
- K122170: Smith & Nephew, Inc. Intramedullary Nail System Instrumentation (2012), 0 descendants of its own
- K110322: Olecra Intramedullary Fixation System (2011), 0 descendants of its own

## Indications for use
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of defonnitr, and for arthordesis.

Source page: https://510kreport.com/device/K032548
Methodology: https://510kreport.com/methodology