# K223227: MAVEN™ Patient-Specific Instrumentation

- Pathway: 510(k) (Special)
- Applicant: Paragon 28, Inc.
- Decided: Nov 17, 2022 after 30 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: 10 generations back to K920802 (1992). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202019: Maven Patient-Specific Instrumentation, Paragon 28, Inc. (2021) Summary page 4.

## Cited in the summary but kept off the family tree
- K211076: Patient Specific Marking Guides, Additive Orthopaedics, LLC (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The MAVEN™ Patient-Specific Instrumentation System 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 MAVEN™ Patient-Specific Instrumentation System 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 MAVEN™ Patient-Specific Instrumentation System 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/K223227
Methodology: https://510kreport.com/methodology