# K080980: Exactech Novation Element Press-Fit Femoral Stems

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: May 6, 2008 after 29 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931641 (1994). 17 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990197: Modulus Compatible Stability (MCS)-HA Total Hip System, Exactech, Inc. (1999) Summary page 2.
- K041906: Exactech 12/14 Total Hip System, Exactech, Inc. (2004) Summary page 2.

## Most influential descendants
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own
- K153649: Exactech® Novation® Element Press-fit Femoral Stem (2016), 5 descendants of its own
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (2016), 4 descendants of its own

## Recalls of this device
- Sep 23, 2015 · Class II · Z-0201-2016: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

## 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/K080980
Methodology: https://510kreport.com/methodology