# K031402: Perfecta Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 22, 2004 after 567 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: 1 generation back to K991123 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991123: Perfecta RS Lateralized Hip Stem, Bridge Hip System, Wrightmedicaltechnologyinc (1999) Summary page 2.
- K004032: Perfecta and Extend, Wrightmedicaltechnologyinc (2001) Summary page 2.

## Indications for use
The PERFECTA® Femoral Stem with calcium sulfate coating is indicated for usc in total hip arthroplasty for reduction or relief of pain amd/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of fractures that are unmanageable using other techniques. The PERFECTA® Fernoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal fernoral heads, acetabular liners and shells, as a part of an Lmcemented total hip arthroplasty

Source page: https://510kreport.com/device/K031402
Methodology: https://510kreport.com/methodology