# K043123: Apex Modular HA Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Apex Surgical, LLC
- Decided: Feb 10, 2005 after 90 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K913231 (1991). 9 ancestors in all.
131 later devices descend from it; 3 cite it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021403: HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral Stem, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K000788: Apex Modular Hip Stem, Apex Surgical, LLC (2000) Summary page 2.

## Most influential descendants
- K071916: Metha Hip System (2008), 68 descendants of its own
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes] (2008), 61 descendants of its own
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own
- K090845: Apex Arc Hip Stem (2010), 58 descendants of its own

## Indications for use
The Apex ModularTM HA Hip Stem is intended for use as the femoral component of a primary or revision 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/K043123
Methodology: https://510kreport.com/methodology