# K000788: Apex Modular Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Apex Surgical, LLC
- Decided: Aug 4, 2000 after 147 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: 1 generation back to K913231 (1991). 4 ancestors in all.
168 later devices descend from it; 8 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913231: S-Rom (TM) Total Lhip System W/Ceramic Head, Joint Medical Products Corp. (1991) Summary page 2.
- K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994) Summary page 2.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 2.
- K921274: Metallic Toatal Hip System, Biomet, Inc. (1994) Summary page 2.

## Most influential descendants
- K043123: Apex Modular HA Hip Stem (2005), 131 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own
- K041950: Apex K2 Hip System (2004), 62 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

## Indications for use
The Apex Modula(m 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/K000788
Methodology: https://510kreport.com/methodology