510(k) · Cleared
ClearedDyna Locking Trochanteric Nail™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innosys · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 3, 2023 as substantially equivalent to K093707 (U&I Corp., 2010) after a 324-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 3, 2023
- Review
- 324 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970097 (1997). 7 ancestors in all, the oldest K860756 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 2 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 1 generation backK093707 Dyna Locking Trochanteric Nail, Model NG0820U&I Corp. · 2010
- This deviceK221084 Dyna Locking Trochanteric Nail™Innosys · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −2 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −1 | K093707 | Dyna Locking Trochanteric Nail, Model NG0820 | U&I Corp. | 2010 | — |
| 0 (this device) | K221084 | Dyna Locking Trochanteric Nail™ | Innosys | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K093707 | Dyna Locking Trochanteric Nail, Model NG0820Summary page 4…8.3040 Common Name: Intramedullary Fixation System Product Code: HSB, HTY Predicate Devices: l Primary - Dyna Locking Trochanteric Nail™ (K093707) l Reference Device - PFNA-II Blade (K182783) Purpose of submission: The purpose of the current submission is 1) to add the n… | 2010 |
| † | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | 2018 |
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 26 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
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. 2023, 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 Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for
alignment, stabilization, fixation of fractures caused by trauma or disease including followings:
- Pertrochanteric fractures
- Intertrochanteric fractures
- Comminuted fractures
- Segmental fractures
- Fracture with bone loss
- Proximal and distal fractures
- Non-unions and malunions
- Subtrochanteric fractures(only for long nail: more than 320mm)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221084: Dyna Locking Trochanteric Nail™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221084
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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