510(k) · Cleared
Recalled · Class II · 2017Panta Nail (Dia. 10MM), Panta Nail XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newdeal Sas · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 29, 2009 as substantially equivalent to K050882 (New Deal, S.A., 2005) and 2 other predicates after a 42-day review. Its family tree reaches back 3 generations to 1998. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 29, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K982953 (1998). 8 ancestors in all, the oldest K974781 (1998). 14 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 2 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- 1 generation backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
- This deviceK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009
- Descendant · cites it directly · 7 of its ownK102413 Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK251850 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc. · 2011 · cites it directly7descendants
- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 3 generations on5descendants
- K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 4 generations on2descendants
- K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −2 | K021786 | Titanium Ankle Arthrodesis Nail | Biomet, Inc. | 2002 | 1 |
| −1 | K050882 | Newdeal Ankle Nail | New Deal, S.A. | 2005 | 5 |
| 0 (this device) | K091788 | Panta Nail (Dia. 10MM), Panta Nail XL | Newdeal Sas | 2009 | — |
| +1 | K102413 | Fuze: Intramedullary Internal Fixation Nail | Vilex, Inc. | 2011 | 3 |
| +2 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +3 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +4 | K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2021 | 3 |
| +3 | K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2025 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050882 | Newdeal Ankle NailSummary page 2…ic Substantial Equivalence: The modified Panta® Nail (dia. 10 mm and XL) is substantially equivalent to commercially marketed device Newdeal Ankle Nail (K050882), Depuy ACE VersaNail (K023115) and BIOMET Ankle Arthrodesis Nail (K021786). Device description The modified Panta ® Nail (dia.… | 2005 |
| * | K023115 | Ace VersanailSummary page 2…Equivalence: The modified Panta® Nail (dia. 10 mm and XL) is substantially equivalent to commercially marketed device Newdeal Ankle Nail (K050882), Depuy ACE VersaNail (K023115) and BIOMET Ankle Arthrodesis Nail (K021786). Device description The modified Panta ® Nail (dia. 10mm and XL) is ideally suited… | 2002 |
| * | K021786 | Titanium Ankle Arthrodesis NailSummary page 2…10 mm and XL) is substantially equivalent to commercially marketed device Newdeal Ankle Nail (K050882), Depuy ACE VersaNail (K023115) and BIOMET Ankle Arthrodesis Nail (K021786). Device description The modified Panta ® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications.… | 2002 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102413 | Fuze: Intramedullary Internal Fixation Nail | 2011 | 7 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | 2018 | 1 |
| K121575 | Oxford Ankle Fusion Nail (Afn) System | 2012 | 1 |
| K181639 | Panta 2 Arthrodesis Nail System | 2018 | 0 |
| K150471 | CalcaNail Orthopedic Arthrodesis Nail | 2015 | 0 |
| K150463 | CalcaNail Orthopedic Nail | 2015 | 0 |
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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K102413 (Vilex, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K050882.
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. 2009, this device’s year, is highlighted.
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 PANTA® Nail system 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 PANTA® Nail system 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 equinovarus, 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/K091788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091788: Panta Nail (Dia. 10MM), Panta Nail XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091788
Report an extraction error
Are you the manufacturer?
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