# K102487: Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Nov 8, 2010 after 70 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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.
54 later devices descend from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042842: Novation 12/14 Press-Fit Femoral Stem, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K162719: iTotal® Hip Replacement System (2017), 17 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. * Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. * Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon * Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K102487
Methodology: https://510kreport.com/methodology