# K083392: Novation 12/14 Cemented Femoral Stems

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Dec 17, 2008 after 30 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961304 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052787: Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series Cemented Femoral Stems (Size 1-5), Exactech, Inc. (2005) Summary page 1.

## Most influential descendants
- K090764: Novation CFS Press-Fit and Cemented Stems (2009), 0 descendants of its own

## Recalls of this device
- Nov 7, 2016 · Class II · Z-1030-2017: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

## 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/K083392
Methodology: https://510kreport.com/methodology