510(k) Report

510(k) · Cleared

Cleared

Epiphysis Screw

K043410510(k) TraditionalCleared Feb 24, 200576-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

I.T.S. Implantat-Technologie-Systeme GmbH · HWC Screw, Fixation, Bone

Cleared on Feb 24, 2005 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 3 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1986. 12 later devices descend from it.

Decided
Feb 24, 2005
Review
76 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K862157 (1986). 4 ancestors in all. 12 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1990: 1 other ancestor2008: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2019: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants clearedK862157 · Omc Orthomet Cannulated Screw · Orthomet, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K862157 · Omc Orthomet Cannulated Screw · Orthomet, Inc. · 19860
  1. Root · 1 generation backK862157 Omc Orthomet Cannulated ScrewOrthomet, Inc. · 1986
  2. This deviceK043410 Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH · 2005
  3. Descendant · cites it directly · 11 of its ownK082949 Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008
  4. Descendant · 2 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
  7. Descendant · 3 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22014: 12016: 12017: 12019: 12020: 22025: 22026: 1
2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp. · 2008 · cites it directly11descendants
  • K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on7descendants
  • K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 3 generations on2descendants
  • K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on2descendants
  • K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K862157Omc Orthomet Cannulated ScrewOrthomet, Inc.1986—
0 (this device)K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH2005—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.2008—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20111
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.20191
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20113
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201410
201610
201710
201910
202020
202520
202610
FIG. 1 — Lineage of K043410, 1986–2026Source: 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? (7)

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
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…ion fastener (see 21 CRF, Sec. 888.3040). DEVICE PRODUCT CODE: HWC SUBSTANTIALLY EQUIVALENT DEVICES: Synthes 6.5mm Cannulated Screw (K(021932) Howmedica Osteonics ASNIS III Cannulated Screw (1(000080) OrthometlWright Medica…
Synthes (Usa)20027
*K000080Asnis Iii Cannulated Screw System
Summary page 1
…T CODE: HWC SUBSTANTIALLY EQUIVALENT DEVICES: Synthes 6.5mm Cannulated Screw (K(021932) Howmedica Osteonics ASNIS III Cannulated Screw (1(000080) OrthometlWright Medical Cannulated Screw (K(862157) Ace/Depuy Cannulated Self Ta…
Howmedica Osteonics Corp.20001
*K862157Omc Orthomet Cannulated Screw
Summary page 1
…ed Screw (K(021932) Howmedica Osteonics ASNIS III Cannulated Screw (1(000080) OrthometlWright Medical Cannulated Screw (K(862157) Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K(903810)…
Orthomet, Inc.1986—
*K903810Ace Cannulated Self Tapping Cancellous Bone Screw
Summary page 1
…OrthometlWright Medical Cannulated Screw (K(862157) Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K(903810) Zimmer MAGNA-Fx Cannulated Screw Fixation system Richards/Smith Nephew Universal…
Ace Medical Co.1990—
*—Zimmer MAGNA-Fx Cannulated Screw Fixation System
Named without a submission number
—
*—Richards/Smith Nephew Universal Cannulated Screw
Named without a submission number
—
*—DePuyAce ACE SCFE Screw
Named without a submission number
—

Also cleared against K021932: 61 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811

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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K082949 (OrthoPediatrics Corp., 2008) has gone furthest, with 11 descendants of its own.
  • 61 other devices also cite its predicate K021932.

How does its category compare?

All HWC devices

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

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?

The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.. Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

Also cleared against K021932

61 other devices cite the same predicate.

  • K252322SIros-X SystemGenesys Spine · 2025
  • K250647SImmetry+ SystemSivantage · 2025
  • K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC · 2025
  • K243838NEXXT MATRIXX® SI SystemNexxt Spine · 2025
  • K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC · 2024
  • K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset…Lesspine Innovations · 2023

More from I.T.S. Implantat-Technologie-Systeme…

13 FDA decisions under this applicant name. See the company

  • K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 20101 recall
  • K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
  • K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 20081 recall
  • K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 20071 recall
  • K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH · 20062 recalls

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
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https://510kreport.com/device/K043410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043410: Epiphysis Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043410

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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