# K964262: Exactech Total Hip Systme: 22MM Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Dec 27, 1996 after 63 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.
146 later devices descend from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthomet: named in the summary without a submission number
- (no number) Zimmer-Charnley Type Total Hip: named in the summary without a submission number
- (no number) Exactech® Femoral Heads: named in the summary without a submission number

## 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

## Indications for use
The Exactech Total Hip System: 22mm Femoral Head is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

Source page: https://510kreport.com/device/K964262
Methodology: https://510kreport.com/methodology