# K093914: Newdeal Compression Plates

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Apr 14, 2011 after 478 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964226 (1997). 11 ancestors in all.
98 later devices descend from it; 1 cites it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070447: Newdeal Compression Plate, Newdeal Sas (2007) Summary page 2.

## Most influential descendants
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K143025: Total Compression Plating System (2014), 24 descendants of its own
- K151442: Total Compression Plating (TCP) System (2015), 23 descendants of its own

## Recalls of this device
- May 22, 2018 · Class II · Z-2446-2018: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- May 22, 2018 · Class II · Z-2443-2018: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- May 22, 2018 · Class II · Z-2447-2018: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- May 22, 2018 · Class II · Z-2444-2018: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
- May 22, 2018 · Class II · Z-2445-2018: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

## Indications for use
The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction. Examples include: * Arthrodesis in hand or foot surgery * Fracture management in the foot or hand * Mono or Bi-cortical osteotomies in the foot or hand * Distal or proximal metatarsal or metacarpal osteotomies * Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc) The Newdeal Uni-C PTM U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints. The size and number of the plate(s) used should be adapted to the specific indication.

Source page: https://510kreport.com/device/K093914
Methodology: https://510kreport.com/methodology