# K050882: Newdeal Ankle Nail

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: May 27, 2005 after 50 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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: 2 generations back to K982953 (1998). 7 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 2.
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 2.
- K021786: Titanium Ankle Arthrodesis Nail, Biomet, Inc. (2002) Summary page 2.

## Most influential descendants
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL (2009), 14 descendants of its own
- K102413: Fuze: Intramedullary Internal Fixation Nail (2011), 7 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own

## Recalls of this device
- Mar 3, 2017 · Class II · Z-1539-2017: Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.
- May 9, 2013 · Class II · Z-1736-2013: As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to i
- May 19, 2011 · Not classified · Z-1428-2012: The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.
- Mar 1, 2010 · Not classified · Z-0308-2011: Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).
- Mar 24, 2008 · Not classified · Z-1877-2008: Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow

## Indications for use
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: - Post-traumatic and degenerative arthritis involving both ankle and subtalar joints - rheumatoid arthritis - revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body - revision of failed total ankle arthroplasty with subtalar intrusion - talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) - avascular necrosis of the talus - Neuroarthropathy or neuropathic ankle deformity - severe deformity as a result of talipes equinovams, cerebral vascular accident, paralysis or other neuromuscular disease - severe pilon fractures with trauma to the subtalar joint

Source page: https://510kreport.com/device/K050882
Methodology: https://510kreport.com/methodology