# K041950: Apex K2 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Apex Surgical, LLC
- Decided: Dec 21, 2004 after 154 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932481 (1994). 8 ancestors in all.
62 later devices descend from it; 3 cite it directly.
0 of 71 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 2.
- K021178: SL-Plus Lateralized Stem, Plus Orthopedics (2002) Summary page 2.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 2.

## Most influential descendants
- 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
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own

## Recalls of this device
- Oct 1, 2021 · Class II · Z-0237-2022: The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

## Indications for use
The Apex K2TM Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; * Rheumatoid arthritis; * Correction of functional deformity; * Congenital dislocation; * Revision procedures where other treatments or devices have failed; * Femoral neck and trochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K041950
Methodology: https://510kreport.com/methodology