# K003235: PE.R.I. II Knee Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 6, 2000 after 20 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
80 later devices descend from it; 3 cite it directly.
0 of 81 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
- K042695: NCB Plating System (2004), 68 descendants of its own
- K061211: NCB Plating System, Proximal Tibia Plates (2006), 25 descendants of its own
- K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V (2008), 21 descendants of its own
- K121672: Aft Proximal Humerus Fracture Plate (2012), 20 descendants of its own
- K100111: NCB Periprosthetic Femur Polyaxial Locking Plate System (2010), 18 descendants of its own

Source page: https://510kreport.com/device/K003235
Methodology: https://510kreport.com/methodology