# K992025: Precision Osteolock Femoral Stems with Pure-Fix HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 13, 1999 after 58 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912395 (1991). 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)
- K912395: Howmedica Precis Osteolock Fem Comp W/Hydro Coat, Howmedica Corp. (1991) Summary page 1.

## Indications for use
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis. This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52’ taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures. The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.

Source page: https://510kreport.com/device/K992025
Methodology: https://510kreport.com/methodology