# K862234: Exactech Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 15, 1986 after 126 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
147 later devices descend from it; 2 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own
- K042842: Novation 12/14 Press-Fit Femoral Stem (2004), 64 descendants of its own
- K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene (2005), 60 descendants of its own
- K070479: Exactech Novation Crown Cup and Liners (2007), 59 descendants of its own
- K102487: Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20 (2010), 54 descendants of its own

Source page: https://510kreport.com/device/K862234
Methodology: https://510kreport.com/methodology