510(k) Report

510(k) · Cleared

Cleared

Dyna Locking IM Nail

K092771510(k) TraditionalCleared Dec 2, 200984-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 Dec 2, 2009 as substantially equivalent to K860756 (Howmedica Corp., 1986) and 3 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1986.

Decided
Dec 2, 2009
Review
84 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K860756 (1986). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestorK860756 · Grosse and Kempf Locking Nail System, Non-Slot Rod · Howmedica Corp. · 1986198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors K860756 · Grosse and Kempf Locking Nail System, Non-Slot Rod · Howmedica Corp. · 19860
  1. Root · 1 generation backK860756 Grosse and Kempf Locking Nail System, Non-Slot RodHowmedica Corp. · 1986
  2. This deviceK092771 Dyna Locking IM NailU&I Corp. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K860756Grosse and Kempf Locking Nail System, Non-Slot RodHowmedica Corp.1986—
0 (this device)K092771Dyna Locking IM NailU&I Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
200810
FIG. 1 — Lineage of K092771, 1986–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K860756Grosse and Kempf Locking Nail System, Non-Slot Rod
Summary page 1
…ification Name: Intramedullary Fixation Rod (HSB), per 21 CFR 888.3020 Product Code: HSB Predicate Devices: Grosse & Kempf Locking Nail System (K860756) Universal Tibial Nail and Unreamed Tibial Nail (K914453) Osteo IC Nail (K933…
Howmedica Corp.1986—
*K914453Universal Tibial Nail and Unreamed Tibial Nail
Summary page 1
…t Code: HSB Predicate Devices: Grosse & Kempf Locking Nail System (K860756) Universal Tibial Nail and Unreamed Tibial Nail (K914453) Osteo IC Nail (K933340) Delta 11Femoral Nail (K981 529)…
Synthes (Usa)1992—
*K933340Osteo Interlocking-Compression Nail
Summary page 1
…Grosse & Kempf Locking Nail System (K860756) Universal Tibial Nail and Unreamed Tibial Nail (K914453) Osteo IC Nail (K933340) Delta 11Femoral Nail (K981 529) T2 Femoral Nail (K081152) Description of De…
Osteo AG1994—
Kept off the family treeK961529FDA’s K961529 is Sas Shigella Boydii Type 12 Antiserum
Our reading of the summary gave K961529, FDA’s number for Sas Shigella Boydii Type 12 Antiserum (Sa Scientific, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Delta 11 Femoral Nail”. Kept off the family tree.
Summary page 2
…y equivalent to Grosse and Kempf Locking Nail System (K860756), Universal Tibial Nail and Unreamed Tibial Nail (K914453), Ostec IC Nail (K933340), Delta 11 Femoral Nail (K961529), T2 Femoral Nail (K081152) in design, performance, function and intended use. Dyna Locking IMNail"'…
Sa Scientific, Inc.1996—
*K081152T2 Femoral Nail
Summary page 1
…ial Nail (K914453) Osteo IC Nail (K933340) Delta 11Femoral Nail (K981 529) T2 Femoral Nail (K081152) Description of Device: The Dyna Locking IM Nailm consists of three types of intramedullary rods (Femoral Nail, Tibial Nail, Un…
Howmedica Osteonics Corp.2008—

Also cleared against K860756: 3 other devices →

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?

  • None of the 4 ancestors has a recall.
  • 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. 2009, 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 IM NailTm is intended to be implanted into the intramedullary canal

of femur or tibia for alignment, stabilization, fixation of fractures caused by trauma or

disease:

* Proximal, middle and distal third femoral and tibial shaft fractures

* Severely comminuted, spiral and segmental fractures

* Nonunions and malunions

* Bone lengthening

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
  • K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp. · 2010
  • 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/K092771 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092771: Dyna Locking IM Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092771

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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