# K962560: Vitality Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Sep 19, 1996 after 80 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
Longest line of descent: 2 generations back to K952191 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952191: Forged Cemented Stem, Encore Orthopedics, Inc. (1995) Summary page 1.
- K961890: Foundation 9MM Forged Cemented Stem, Encore Orthopedics, Inc. (1996) Summary page 1.
- K885146: CL Universal Hip Device, Lima Intl. Corp. (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- K910830: Invalift, American Invalift Corp. (1992). Our OCR of the scanned summary read K910830, FDA’s number for Invalift (American Invalift Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lima Universal Stem”. Kept off the family tree. Summary page 1.

## Indications for use
The Vitality Hip stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar, bipolar and CoCrMo femoral heads.

Source page: https://510kreport.com/device/K962560
Methodology: https://510kreport.com/methodology