# K961732: KAR

- Pathway: 510(k) (Traditional)
- Applicant: Landos, Inc.
- Decided: Jul 8, 1997 after 431 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 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) Osteonics Restoration Monolithic Hip: named in the summary without a submission number
- (no number) Implex F-220 Press-Fit Femoral System: named in the summary without a submission number
- (no number) Landanger-Landos Corail Hip: named in the summary without a submission number

## Most influential descendants
- K093736: Depuy Corail Hip System, Revision Stem (2011), 14 descendants of its own
- K192946: DePuy Corail AMT Hip Prosthesis (2019), 10 descendants of its own
- K211657: EMPHASYS Femoral Stems (2021), 7 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K203167: DePuy Corail AMT Hip Prosthesis (2020), 2 descendants of its own

## Indications for use
This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Source page: https://510kreport.com/device/K961732
Methodology: https://510kreport.com/methodology