# K021346: Stem Hip Replacement System, Model PHA002XX

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 2, 2002 after 64 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 11 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112080: Preserve Hip Stem (2011), 8 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own
- K150302: PROFEMUR Preserve Classic Stem (2015), 4 descendants of its own
- K112150: Profemur Gladiator HA Hip Stem (2011), 4 descendants of its own
- K150133: PROFEMUR Preserve Size 1-3 Hip Stems (2015), 3 descendants of its own

## Recalls of this device
- Sep 5, 2012 · Class II · Z-0183-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0184-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0185-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

## Indications for use
Indicated for use in total hip arthroplasty for reduction or relief of pain and/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.

Source page: https://510kreport.com/device/K021346
Methodology: https://510kreport.com/methodology