# K041353: Furlong H-AC Total Hip Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Jri Manufacturing, Ltd.
- Decided: Oct 8, 2004 after 141 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Indications for the Furlong® H-AC Total Hip Replacement System are: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis * Correction off functional deformity * Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K041353
Methodology: https://510kreport.com/methodology