510(k) · Cleared
Recalled · Class II · 2017Newdeal Ankle Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 27, 2005 as substantially equivalent to K983942 (Smith & Nephew, Inc., 1998) and 2 other predicates after a 50-day review. Its family tree reaches back 2 generations to 1998. 15 later devices descend from it. It has been recalled 5 times.
- Decided
- May 27, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K982953 (1998). 7 ancestors in all, the oldest K974781 (1998). 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 1 generation backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- This deviceK050882 Newdeal Ankle NailNew Deal, S.A. · 2005
- Descendant · cites it directly · 14 of its ownK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
- Descendant · 2 generations on · 7 of its ownK102413 Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 4 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · 5 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · cites it directly14descendants
- K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · 2 generations on7descendants
- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 4 generations on5descendants
- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −1 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| 0 (this device) | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | — |
| +1 | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | 2 |
| +2 | K102413 | Fuze: Intramedullary Internal Fixation Nail | Vilex, Inc. | 2011 | 3 |
| +3 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +4 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +5 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 2…ivalent in terms of design, indications for use and dimensions with the following predicate devices: Smith & Nephew ReVision Nail K983942 DePuy VersaNail K023115 Biomet Ankle Arthrodesis Nail… | 1998 |
| * | K023115 | Ace VersanailSummary page 2…with the following predicate devices: Smith & Nephew ReVision Nail K983942 DePuy VersaNail K023115 Biomet Ankle Arthrodesis Nail K021786 H. Comparison of Technological Characteristics… | 2002 |
| * | K021786 | Titanium Ankle Arthrodesis NailSummary page 2…ReVision Nail K983942 DePuy VersaNail K023115 Biomet Ankle Arthrodesis Nail K021786 H. Comparison of Technological Characteristics… | 2002 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2017 | Class II | Z-1539-2017 | Packaging change control | 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 | Device Design | 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 issue this voluntary medical device… |
| May 19, 2011 | Not classified | Z-1428-2012 | Use error | 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 | Nonconforming Material/Component | 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 | Process control | 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 the engagement of the threaded part… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K091788 (Newdeal Sas, 2009) has gone furthest, with 14 descendants of its own.
- 17 other devices also cite its predicate K983942.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
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…
Read the full statement (108 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050882 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050882: Newdeal Ankle Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050882
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026