# K111863: Signature Planner,Signature Guides

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jun 15, 2012 after 351 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K905070 (1991). 24 ancestors in all.
71 later devices descend from it; 5 cite it directly.
0 of 96 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.
- K102795: Signature Planner; Signature Guides, Materialise NV (2011) Summary page 2.
- K031454: Acumen Surgical Navigation System, Biomet, Inc. (2004) Summary page 2.
- (no number) Instrument: named in the summary without a submission number

## Most influential descendants
- 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
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own

## Indications for use
The Signature TM Personalized Patient Care System - Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans. The SignatureT M Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components. The Signature"4 guides are intended for single use only.

Source page: https://510kreport.com/device/K111863
Methodology: https://510kreport.com/methodology