# K202019: Maven Patient-Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jan 14, 2021 after 177 days
- Product code: HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K920802 (1992). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170968: PROPHECY INVISION Pre-operative Navigation System, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System, Paragon 28, Inc. (2020) Summary page 5.

## Most influential descendants
- K223227: MAVEN™ Patient-Specific Instrumentation (2022), 0 descendants of its own

## Indications for use
The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended to be used as patient specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively and in guiding the marking of bone before cutting. The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans. The Paragon 28 MAVENT™ Patient-Specific Instrumentation is intended for single use only. The Paragon 28 TAR Patient-Specific Case Reports are intended for use with the Paragon 28 APEX 3D Total Ankle Replacement System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

Source page: https://510kreport.com/device/K202019
Methodology: https://510kreport.com/methodology