510(k) · Cleared
ClearedAgile Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Apr 23, 2018 as substantially equivalent to K070843 (Synthes (Usa), 2007) and 1 other predicate after a 228-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Apr 23, 2018
- Review
- 228 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982953 (1998). 11 ancestors in all, the oldest K981529 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 2 generations backK993956 Titanium Pediatric Femoral NailBiomet, Inc. · 1999 · Recalled
- 1 generation backK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
- This deviceK172699 Agile NailOrthofix Srl · 2018
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 | K993956 | Titanium Pediatric Femoral Nail | Biomet, Inc. | 1999 | 11 |
| −1 | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | 27 |
| 0 (this device) | K172699 | Agile Nail | Orthofix Srl | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K070843 | Synthes Adolescent Lateral Entry Femoral Nail SystemSummary page 4…icate Device Name 510(k) Manufacturer Number Synthes Adolescent Lateral Entry K070843 Synthes(USA) Femoral Nail System Orthopediatrics PediNal Intramedullary K083726 Orthopediatrics, Corp… | 2007 |
| * | K083726 | Pedinail Intramedullary Nailing SystemSummary page 4…Number Synthes Adolescent Lateral Entry K070843 Synthes(USA) Femoral Nail System Orthopediatrics PediNal Intramedullary K083726 Orthopediatrics, Corp. Nailing System Device description The Agile Nail consists of ante grade intramedullar… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 7 of the 11 ancestors have a recall of any class.
- 4 other devices also cite its predicate K070843.
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. 2018, 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 Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities.
It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal.
The indications include:
prophylactic nailing of impending pathologic fractures;
fixation of femurs that have been surgically prepared (osteotomy);
nonunions and malunions;
reconstruction following tumor resection and grafting and bone lengthening and shortening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172699: Agile Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172699
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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