# K123000: Integra Total Foot Systems

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Dec 21, 2012 after 85 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 3 generations back to K000684 (2000). 9 ancestors in all.
54 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100502: Ascension Total Plate System, Ascension Orthopedics, Inc. (2010) Summary page 2.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.
- K094037: TC Plating System, Ortho-Pro, LLC (2010) Summary page 1.
- K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2010) Summary page 2.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 2.

## Most influential descendants
- K132594: Crosscheck Plating System (2013), 23 descendants of its own
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own
- K163293: Colink™ Plating System (2017), 21 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K172300: CoLink View Plating System (2017), 16 descendants of its own

## Indications for use
INTEGRA® Total Foot System is indicated for skeletally mature patients for the following: - Stabilization and fixation of fresh fractures - Intra and extra articular fractures, joint depression, and multi-fragmentary fractures - Revision procedures, joint fusion, and reconstruction of small bones of the feet.

Source page: https://510kreport.com/device/K123000
Methodology: https://510kreport.com/methodology