# K033313: Quatro M Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: Jul 28, 2004 after 287 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K964616 (1997). 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)
- K964616: Quatroloc Plasma Sprayed Femoral Component, Whiteside Biomechanics, Inc. (1997) Summary page 1.

## Indications for use
The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use It is intended to be used for: Noninflammatory degenerative joint disease including osteoarthritis 2 Rheumatoid arthritis 3. Avascular necrosis 4. Correction of functional deformity 5. Revision procedures where other treatments or devices have failed 6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

Source page: https://510kreport.com/device/K033313
Methodology: https://510kreport.com/methodology