# K960856: Konstruct Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 27, 1996 after 271 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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) AGC Total Knee System Patellar Component: named in the summary without a submission number
- (no number) Total Condylar Knee Prosthesis: named in the summary without a submission number

## Most influential descendants
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## Indications for use
The Konstruct Patellar Component is indicated for patients suffering from severe knee pain and disability. Specific indications include patellar replacement in patients who require implantation due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudo-gout or complications from a failed prosthesis. The device is for use with bone cement only and for supplemental fixation by means of suture attached. Supplemental suture attachment is used in cases where soft tissues (tendons, ligaments) have ruptured or require reattachment.

Source page: https://510kreport.com/device/K960856
Methodology: https://510kreport.com/methodology