# K141797: Alteon 6.5MM Bone Screws

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 29, 2014 after 27 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: 2 generations back to K921114 (1993). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component, Exactech, Inc. (1999) Summary page 1.

## Most influential descendants
- K182346: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (2018), 5 descendants of its own
- K241597: Freedom® Total Knee System - Porous Tibial Base Plate (2025), 3 descendants of its own
- K251717: Freedom® Total Knee System – Titanium Tibial Base Plate (2025), 1 descendant of its own
- K252777: Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (2025), 0 descendants of its own
- K253314: Freedom Infinia™ Total Knee System (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 arc 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. * Femnoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K141797
Methodology: https://510kreport.com/methodology