510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

3.7MM/5.0MM Dynamic Locking Screw

K110592510(k) TraditionalCleared Jul 25, 2011145-day reviewClass II21 CFR 888.3040Recalls 2

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

Synthes USA · HWC Screw, Fixation, Bone

Cleared on Jul 25, 2011 as substantially equivalent to K101696 (Zimmer, Inc., 2010) and 4 other predicates after a 145-day review. Its family tree reaches back 4 generations to 1996. It has been recalled 2 times.

Decided
Jul 25, 2011
Review
145 days
Class
Class II
Product code
HWC
Recalls
2
Predicates
5

Its longest line of descent runs back 4 generations to K961413 (1996). 13 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 3 other ancestors1996: 1 other ancestor2008: 1 other ancestor2006: 1 other ancestor2003: 2 other ancestors2001: 1 other ancestorK961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 1996K042695 · NCB Plating System · Zimmer GmbH · 2004 · recalledK061211 · NCB Plating System, Proximal Tibia Plates · Zimmer GmbH · 2006 · recalledK101696 · Motionloc Screw for NCB Polyaxial Locking Plating System · Zimmer, Inc. · 20101995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 5 other ancestors K101696 · Motionloc Screw for NCB Polyaxial Locking Plating System · Zimmer, Inc. · 2010K061211 · NCB Plating System, Proximal Tibia Plates · Zimmer GmbH · 2006 · recalledK042695 · NCB Plating System · Zimmer GmbH · 2004 · recalledK961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 19960
  1. Root · 4 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
  2. 3 generations backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
  3. 2 generations backK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
  4. 1 generation backK101696 Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010
  5. This deviceK110592 3.7MM/5.0MM Dynamic Locking ScrewSynthes USA · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K961413Synthes Anatomical Locking Plate SystemSynthes (Usa)1996—
−3K042695NCB Plating SystemZimmer GmbH20041
−2K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH20064
−1K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.2010—
0 (this device)K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200030
200110
200320
200610
200810
FIG. 1 — Lineage of K110592, 1996–2011Source: 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? (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
*K101696Motionloc Screw for NCB Polyaxial Locking Plating System
Summary page 1
…ss 11 888.3030 - smooth or threaded metallic bone fixation fastener H WC Predicate Device: K 101696 - Zimmer Motion Loc Screw for NCB Polyaxial Locking Plate System…
Zimmer, Inc.2010—
*K961413Synthes Anatomical Locking Plate System
Summary page 1
…Predicate Device: K 101696 - Zimmer Motion Loc Screw for NCB Polyaxial Locking Plate System K961413 - Synthes Anatomical Locking Plate System K(963192 - Synthes 3.5/4.0mm Cannulated Screws…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…Locking Plate System K961413 - Synthes Anatomical Locking Plate System K(963192 - Synthes 3.5/4.0mm Cannulated Screws K(000682 - Synthes Large Fragment Dynamic Compression Locki…
Synthes (Usa)1996—
*K000682Synthes Large Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…K961413 - Synthes Anatomical Locking Plate System K(963192 - Synthes 3.5/4.0mm Cannulated Screws K(000682 - Synthes Large Fragment Dynamic Compression Locking System K(000…
Synthes (Usa)2000—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…ws K(000682 - Synthes Large Fragment Dynamic Compression Locking System K(000684 - Synthes Small Fragment Dynamic Compression Locking System Device Description: The…
Synthes (Usa)20001

Also cleared against K101696: 4 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)

Recalls of this device

DateClassRecallRoot causeReason
Aug 11, 2015Class IIZ-2794-2015Labeling False and MisleadingDLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of…
Jul 22, 2013Class IIZ-0390-2014Labeling False and MisleadingAll lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 5 of the 13 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K101696.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

Indications for use as stated in the FDA summary.

Also cleared against K101696

4 other devices cite the same predicate.

  • K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
  • K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013
  • K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
  • K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013

More from Synthes USA

9 FDA decisions under this applicant name. See the company

  • K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015
  • K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012
  • K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  • K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA · 2012
  • K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 20121 recall

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/K110592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110592: 3.7MM/5.0MM Dynamic Locking Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110592

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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