# K110415: Signature Planner / Signature Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: May 16, 2011 after 91 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 8 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102795: Signature Planner; Signature Guides, Materialise NV (2011) Summary page 1.
- K082358: Smith & Nephew, Inc. Patient Matched Technology, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K173445: Materialise TKA Guide System (2018), 9 descendants of its own
- K112301: Zimmer Patient Specific Instruments Planner (2012), 7 descendants of its own
- K172650: Materialise PKA Guide System (2017), 6 descendants of its own
- K173970: Materialise PKA Guide System (2018), 5 descendants of its own
- K211512: VISIONAIRE UK Patient Matched Cutting Guides (2021), 3 descendants of its own

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0628-2014: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

## Indications for use
Signaturet " Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Signaturet " Personalized Patient Care System can be used with the following Biomete Knee Systems and their respective components: Vanguard TM Complete Knee System, Vanguard T" M Unicompartmental Knee System, Vanguard"TI SK 360, Vanguard T" SSK Revision Knee System, Regenerext " Primary Tibial System, Offset & Microplasty Tibial Systems, Maxi mT" Complete Knee System, Ascent'" Total Knee System, and AGC'" Complete Knee system. The Signature'" guides are intended for single use only.

Source page: https://510kreport.com/device/K110415
Methodology: https://510kreport.com/methodology