# K103598: Prophecy Pre-Operative Navigation Alignment Guides

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 17, 2011 after 313 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: 2 generations back to K972626 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093405: Prophecy Pre-Operative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Most influential descendants
- K213817: MPO Knee Instruments; MPO PROPHECY Knee Instruments (2022), 0 descendants of its own

## Indications for use
Wright's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with Wright's ADVANCE® and EVOLUTION™ Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

Source page: https://510kreport.com/device/K103598
Methodology: https://510kreport.com/methodology