510(k) Report

510(k) · Cleared

Cleared

Dyna Locking Trochanteric Nail, Model NG0820

K093707510(k) TraditionalCleared Jun 23, 2010203-day reviewClass II21 CFR 888.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

U&I Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jun 23, 2010 as substantially equivalent to K860756 (Howmedica Corp., 1986) and 4 other predicates after a 203-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.

Decided
Jun 23, 2010
Review
203 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K970097 (1997). 6 ancestors in all, the oldest K860756 (1986). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1986: 1 other ancestor2023: 1 descendant clearedK970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 1997K973240 · Synthes Proximal Femoral Nail (PFN) System Modification · Synthes (Usa) · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K973240 · Synthes Proximal Femoral Nail (PFN) System Modification · Synthes (Usa) · 1997K970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 19970
  1. Root · 2 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 1 generation backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
  3. This deviceK093707 Dyna Locking Trochanteric Nail, Model NG0820U&I Corp. · 2010
  4. Descendant · cites it directly · 0 of its ownK221084 Dyna Locking Trochanteric Nail™Innosys · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K221084Dyna Locking Trochanteric Nail™Innosys · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−1K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa)1997—
0 (this device)K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp.2010—
+1K221084Dyna Locking Trochanteric Nail™Innosys2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199610
199810
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K093707, 1997–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K860756Grosse and Kempf Locking Nail System, Non-Slot Rod
Summary page 2
…ures *Non-unions and malunions Substantial Equivalence: The Dyna Locking Trochanteric Nailm is substantially equivalent to Grosse and Kempf Locking Nail System (K860756), Delta 11Femoral Nail (K981529), T2 Femoral Nail (K081152), Proximal Femoral Nail System (K973240), Dynamic Hip Screw (K953607)…
Howmedica Corp.1986—
*K981529Titanium Intramedullary Nail, Titanium Locking Screw
Summary page 1
…21 CFR 888.3020 Product Code: HSB Predicate Devices: Grosse and Kempf Locking Nail System (K8,60756) Delta 11Femoral Nail (K981529) T2 Femoral Nail (K081152) Proximal Femoral Nail System (K973240)…
Smith & Nephew, Inc.19982
*K081152T2 Femoral Nail
Summary page 1
…icate Devices: Grosse and Kempf Locking Nail System (K8,60756) Delta 11Femoral Nail (K981529) T2 Femoral Nail (K081152) Proximal Femoral Nail System (K973240) Dynamic Hip Screw (K953607) Descr…
Howmedica Osteonics Corp.2008—
*K973240Synthes Proximal Femoral Nail (PFN) System Modification
Summary page 1
…756) Delta 11Femoral Nail (K981529) T2 Femoral Nail (K081152) Proximal Femoral Nail System (K973240) Dynamic Hip Screw (K953607) Description of Device: The Dyna Locking Trochanteric NaiITm consists…
Synthes (Usa)1997—
*K953607Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)
Summary page 1
…981529) T2 Femoral Nail (K081152) Proximal Femoral Nail System (K973240) Dynamic Hip Screw (K953607) Description of Device: The Dyna Locking Trochanteric NaiITm consists of intramedullary rod, neck screw assembly(neck screw…
Synthes (Usa)1996—

Also cleared against K860756: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221084Dyna Locking Trochanteric Nail™Innosys20230

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 13 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K221084 (Innosys, 2023) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K860756.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Dyna Locking Trochanteric NaiITM 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

*Subtrochanteric fractures

* Intertrochanteric fractures

* Comminuted fractures

* Segmental fractures

*Fracture with bone loss

* Proximal and distal fractures

* Non-unions and malunions

Indications for use as stated in the FDA summary.

Also cleared against K860756

3 other devices cite the same predicate.

  • K120419Dyna Locking Ankle NailU&I Corp. · 2012
  • K092771Dyna Locking IM NailU&I Corp. · 2009
  • K973944Orthofix Femoral Nailing SytemOrthofix Srl · 1997

More from U&I Corp.

12 FDA decisions under this applicant name. See the company

  • K140864Veloxtm Interbody Fusion SystemU&I Corp. · 2014
  • K140234Aspiron Acp SystemU&I Corp. · 2014
  • K132926Velofixtm Interbody Fusion SystemU&I Corp. · 2014
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012
  • K112240Dyna Locking Cannulated ScrewU&I Corp. · 2012

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K093707 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093707: Dyna Locking Trochanteric Nail, Model NG0820.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093707

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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