# K051642: FR.O.H. Calcaneus Repair System

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. Implantat-Technologie-Systeme GmbH
- Decided: Aug 22, 2005 after 63 days
- Product code: NDF (Plate, Fixation, Bone, Non-Spinal, Metallic)
- 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
Longest line of descent: 2 generations back to K981372 (1998). 5 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K993465: Depuy Ace Calcaneal Peri-Articular Plate, Depuy, Inc. (2000) Summary page 1.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 1.

## Most influential descendants
- K060156: Straight Plate with Angular Stability & Screw System (2006), 27 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K063166: I.T.S. Pelvic Reconstruction System (2006), 9 descendants of its own
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K161904: GEO Bone Screw System (2017), 4 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1595-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

## Indications for use
The I.T.S. FR.O.M. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot. Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tongue type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients. This system is not intended for spinal use.

Source page: https://510kreport.com/device/K051642
Methodology: https://510kreport.com/methodology