# K964395: Patient Specific Implant (Psi) Hip Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Hayes Medical, Inc.
- Decided: Jan 27, 1997 after 84 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 1 cites it directly.
0 of 67 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) Patient Matched Implant (PMI) Hip Femoral Component: named in the summary without a submission number

## Most influential descendants
- K033242: Knee Interpositional Mini-Repair System (Kimrs) (2003), 65 descendants of its own
- K043570: Unicondylar Knee Repair System / Conformis Ucd (2005), 62 descendants of its own
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 40 descendants of its own

## Indications for use
The PSI device Is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture or the failure of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.

Source page: https://510kreport.com/device/K964395
Methodology: https://510kreport.com/methodology