# K984492: Tigran Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Ponmed, Ltd.
- Decided: Mar 15, 1999 after 88 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850055 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 1.
- K915594: Stability Hip Femoral Component, Depuy, Inc. (1993) Summary page 1.

## Indications for use
1) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur 2). Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; 3) Patients suffering from disability due to previous fusion; 4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity; 5) Patients with acute femoral neck fractures.

Source page: https://510kreport.com/device/K984492
Methodology: https://510kreport.com/methodology