# K020989: Super Eon Plus Femoral Stems

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 26, 2002 after 30 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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: 1 generation back to K983226 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983226: Osteonics X Cemented Hip Stem Series, Osteonics Corp. (1998) Summary page 1.

## Recalls of this device
- Nov 13, 2008 · Not classified · Z-0900-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
Indications for use as a Bipolar or Hemi-Hip Replacement: • Femoral head/neck fractures or non-unions • Aseptic necrosis of the femoral head; • Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion; • Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum; • Salvage of failed total hip arthroplasty. Indications for use as part of a Total Hip Replacement include: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular Necrosis; • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Source page: https://510kreport.com/device/K020989
Methodology: https://510kreport.com/methodology