# K935080: Insall-Burstein II

- Pathway: 510(k) (Traditional)
- Applicant: Hospital For Special Surgery
- Decided: May 22, 1995 after 574 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120038: A200 Knee System (2013), 2 descendants of its own
- K190122: Renovis A200 PS Knee System as part of the Renovis A200 Knee System (2019), 1 descendant of its own
- K243295: Initia Knee System (2025), 0 descendants of its own
- K240043: EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (2024), 0 descendants of its own
- K140222: Saiph Knee System (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K935080
Methodology: https://510kreport.com/methodology