# K102795: Signature Planner; Signature Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 2, 2011 after 128 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924630 (1993). 7 ancestors in all.
99 later devices descend from it; 7 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073449: Surgicase, Materialise NV (2008) Summary page 1.
- K093533: Zimmer Patient Specific Instruments System, Version 2.0, Materialise NV (2010) Summary page 2.

## Most influential descendants
- K111863: Signature Planner,Signature Guides (2012), 71 descendants of its own
- K121640: Zimmer Patient Specific Instruments System (2012), 60 descendants of its own
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own
- K130126: Signature Personalized Patient Care System - Glenoid Guide System (2013), 38 descendants of its own
- K131559: Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides (2013), 35 descendants of its own

## Recalls of this device
- May 3, 2016 · Class II · Z-1941-2016: A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior
- Sep 23, 2015 · Class II · Z-0162-2016: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
- Feb 4, 2015 · Class II · Z-1287-2015: Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of 
- Aug 4, 2011 · Not classified · Z-1145-2012: Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distr

## Indications for use
Signature m Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The SignatureTM Personalized Patient Care System can be used with the following Biomet knee systems and their respective components: Vanguard' Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent TM Total Knee System, and AGC® Complete Knee system. The SignatureTM guides are intended for single use only.

Source page: https://510kreport.com/device/K102795
Methodology: https://510kreport.com/methodology