# K140257: Signature Planner, Signature Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 2, 2014 after 58 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 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.
- K110415: Signature Planner / Signature Guides, Materialise NV (2011) Summary page 3.
- K122160: Vanguard XP Knee System, Biomet Manufacturing Corp (2013) Summary page 2.

## Indications for use
Pin Placement Guides Signature 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 Signature Personalized Patient Care System can be used with the following Biomet 0 Knee Systems and their respective components: Vanguard' Complete Knee System, Vanguard" 55K 360, Vanguard M SSI< Revision Knee System, Regenerex' Primary Tibial System, Offset &. Microplasty" Tibial Systems, Maxim" Complete Knee System, Ascent" Total Knee System, AGCM Complete Knee system and Vanguard' X<P Knee system. Cut-Through Guides Signature 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 Signature Personalized Patient care System can be used with the following Biometo Knee Systems and their respective components: Vanguard' Complete Knee System, Vanguard MM Unicompartmental Knee System, Vanguard'" SSK 360, Vanguard" S5K Revision Knee System, Regenerex TM Primary Tibial System, Offset & Micropla styT' Tibial Systems, Maxim' TM Complete Knee System, Ascent'" Total Knee System, AGC M Complete Knee system and Vanguard'" XP Knee system. The Signature Personalized Patient Care System is compatible for use with the OxfordO Partial Knee System as approved in P010014/531. The Signature guides are intended for single use only.

Source page: https://510kreport.com/device/K140257
Methodology: https://510kreport.com/methodology