# K041786: Calcamea Plate

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Sep 8, 2004 after 69 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: 2 generations back to K915818 (1992). 6 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 20 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 2.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 2.
- K993465: Depuy Ace Calcaneal Peri-Articular Plate, Depuy, Inc. (2000) Summary page 2.
- K981775: Depuy Ace Timax Calcaneal Peri-Articular Plate, Depuy Ace Medical Co. (1998) Summary page 2.

## Most influential descendants
- K090582: Calcaneal Fracture Plate System (2009), 12 descendants of its own
- K132898: A.L.P.S. Calcaneal Plating System (2013), 11 descendants of its own
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own

## Indications for use
The CALCANEA TM -PLATE is indicated for use in fixation of fractures or osteotomies of the calcaneus.

Source page: https://510kreport.com/device/K041786
Methodology: https://510kreport.com/methodology