# K972641: Dual Offset Perfecta Imc Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 9, 1997 after 86 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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® IMC Hip Stem manufactured by Wright Medical Technology, Inc.: named in the summary without a submission number

## Most influential descendants
- K061344: Excia Total Hip System Lateral Offset (2006), 4 descendants of its own
- K092143: Excia Total Hip System M an ML Femoral Stem (2009), 3 descendants of its own
- K140915: Excia Total Hip System (2014), 2 descendants of its own
- K150062: Excia Total Hip System (2015), 1 descendant of its own
- K172235: CoreHip® System (2018), 0 descendants of its own

## Indications for use
This device is indicated 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 function 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. This device is intended for use with bone cement.

Source page: https://510kreport.com/device/K972641
Methodology: https://510kreport.com/methodology