# K964218: Perfecta Plasma Spray Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 8, 1997 after 78 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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 its predicate without a number.
- (no number) PERFECTA® Plasma Spray Hip System: named in the summary without a submission number
- (no number) PERFECTA® Revision Hip System: named in the summary without a submission number

## Most influential descendants
- K062775: European Style Taper,Press-Fit Hip Stem (2007), 13 descendants of its own
- K131022: Ovation 10/12 Hip Stem (2013), 5 descendants of its own
- K141001: Alpine Hip Stem; Alpine HA Hip Stem (2014), 4 descendants of its own
- K173880: Corin TriFit CF Hip Stem (2018), 3 descendants of its own
- K133386: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem (2014), 3 descendants of its own

## Indications for use
The PERFECTA® Plasma Spray Hip System is 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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K964218
Methodology: https://510kreport.com/methodology