# K022324: Normed Titanium Calcaneus Plating with Locking Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Sep 17, 2002 after 62 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
86 later devices descend from it; 4 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own

## Recalls of this device
- Apr 14, 2009 · Not classified · Z-1524-2009: Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat 

## Indications for use
Normed Titanium Calcaneus Plating with Locking Screw System intended for use in Intra and extra -artcular fiactures, joint depression, non-displaced and tonque type, multifiagmentary fractures, stabilization and fixation of fiesh f?actures, revision procedures, joint fiision, and reconstruction of calcaneus bones. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K022324
Methodology: https://510kreport.com/methodology