# K153649: Exactech® Novation® Element Press-fit Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 31, 2016 after 254 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931641 (1994). 18 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080980: Exactech Novation Element Press-Fit Femoral Stems, Exactech, Inc. (2008) Summary page 4.

## Most influential descendants
- K171249: Entrada™ hip stem (2017), 2 descendants of its own
- K233758: Trivicta™ Hip Stem (2024), 1 descendant of its own
- K162732: Exactech® Alteon® HA Femoral Stem (2017), 1 descendant of its own
- K251052: Trivicta® Hip Stem (2025), 0 descendants of its own
- K243839: Alteon® HA Femoral Stems (2025), 0 descendants of its own

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. • Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.

Source page: https://510kreport.com/device/K153649
Methodology: https://510kreport.com/methodology