# K211614: CenterMed Patient Matched Assisted Surgical Planning (ASP) System

- Pathway: 510(k) (Traditional)
- Applicant: Centermed, Inc.
- Decided: Aug 4, 2022 after 435 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K924630 (1993). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192979: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2020) Summary page 4.

## Most influential descendants
- K223421: MedCAD AccuPlan Orthopedics System (2023), 0 descendants of its own

## Indications for use
CenterMed Patient Matched Assisted Surgical Planning (ASP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models of the Fibula and Ilium, surgical guides for harvesting bone grafts from the Fibula or Ilium, and surgical planning case reports for use in Maxillofacial reconstructive surgeries. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K211614
Methodology: https://510kreport.com/methodology