# K002335: Natural-Knee II System-Durasul Tibial Insert and Durasul All-Poly Patella

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Oct 25, 2000 after 85 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 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

## Recalls of this device
- Dec 21, 2011 · Not classified · Z-0851-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0852-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0849-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0854-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0855-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0848-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0850-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 
- Dec 21, 2011 · Not classified · Z-0853-2012: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella 

Source page: https://510kreport.com/device/K002335
Methodology: https://510kreport.com/methodology