# K121684: Novation Lpi Prime Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 1, 2012 after 116 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: 9 generations back to K955033 (1996). 91 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 92 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080584: Metha Short Stem Hip System, Aesculap Implant System, Inc. (2008) Summary page 1.
- K112682: Metha Hip System, Aesculap Implant Systems, LLC (2012) Summary page 1.

## Most influential descendants
- K141821: Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset (2014), 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. 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. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K121684
Methodology: https://510kreport.com/methodology