510(k) Report

510(k) · Cleared

Cleared

Dyna Locking Cannulated Screw

K112240510(k) TraditionalCleared Jan 4, 2012153-day reviewClass II21 CFR 888.3040

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

U&I Corp. · HWC Screw, Fixation, Bone

Cleared on Jan 4, 2012 as substantially equivalent to K951389 (Smith & Nephew Richards, Inc., 1995) and 5 other predicates after a 153-day review. Its family tree reaches back 1 generation to 1995. 14 later devices descend from it.

Decided
Jan 4, 2012
Review
153 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K951389 (1995). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1996: 4 other ancestors2016: 1 descendant cleared2023: 6 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants clearedK951389 · Reunion Bone Screw System · Smith & Nephew Richards, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants K951389 · Reunion Bone Screw System · Smith & Nephew Richards, Inc. · 19950+5
  1. Root · 1 generation backK951389 Reunion Bone Screw SystemSmith & Nephew Richards, Inc. · 1995
  2. This deviceK112240 Dyna Locking Cannulated ScrewU&I Corp. · 2012
  3. Descendant · cites it directly · 13 of its ownK153656 PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016
  4. Descendant · 2 generations on · 11 of its ownK181600 PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2018
  5. Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
  6. Descendant · 4 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
  7. Descendant · 4 generations on · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12021: 22022: 12023: 62024: 12026: 2
2016high 6 (2023) · low 0 (2017)2026

Most influential descendants

Showing 5 of 14 · See all
  • K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016 · cites it directly13descendants
  • K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2018 · 2 generations on11descendants
  • K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
  • K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 4 generations on6descendants
  • K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K951389Reunion Bone Screw SystemSmith & Nephew Richards, Inc.1995—
0 (this device)K112240Dyna Locking Cannulated ScrewU&I Corp.2012—
+1K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.2016—
+2K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.2018—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System…Aegis Spine2021—
+4K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon…Aegis Spine, Inc.2022—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199640
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
202120
202210
202360
202410
202620
FIG. 1 — Lineage of K112240, 1995–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (6)

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
*K951389Reunion Bone Screw System
Summary page 1
…ed metallic bone fixation fastener Product Code: HWC - Screw, Fixation, Bone Predicate Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011)…
Smith & Nephew Richards, Inc.1995—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…Product Code: HWC - Screw, Fixation, Bone Predicate Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011) Description of Device: The Dyna Locking Cannulated ScrewTM c…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…ode: HWC - Screw, Fixation, Bone Predicate Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011) Description of Device: The Dyna Locking Cannulated ScrewTM consists of…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…HWC - Screw, Fixation, Bone Predicate Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011) Description of Device: The Dyna Locking Cannulated ScrewTM consists of various…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…Predicate Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011) Description of Device: The Dyna Locking Cannulated ScrewTM consists of various sizes of cannulated screws and wash…
Synthes (Usa)20027
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…e Devices: Richards Cannulated Screw (K951 389) Synthes Cannulated Screw (K962823, K9631 92, K963172, K021932, K962011) Description of Device: The Dyna Locking Cannulated ScrewTM consists of various sizes of cannulated screws and washers. Cann…
Synthes (Usa)1996—

Also cleared against K951389: 1 other device →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613

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?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K153656 (L&K BIOMED Co., Ltd., 2016) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K951389.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

Intracapsular fractures of the femoral neck

Intertrochanteric fractures of the femur

Tibial plateau fractures

Fractures of the dorsal pelvic ring

Pelvic sacroiliac joint disruption

Ankle arthrodesis

Other indications where canceilous screws are currently used and a guided system may be beneficial

Indications for use as stated in the FDA summary.

Also cleared against K951389

1 other device cites the same predicate.

  • K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC · 2017

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
  • K102367Optigen Total Knee SystemU&I Corp. · 2010

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K112240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112240: Dyna Locking Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112240

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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