510(k) Report

510(k) · Cleared

Cleared

Modification to Asnis Iii Cannulated Screw System

K024060510(k) SpecialCleared Dec 20, 200211-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

Howmedica Osteonics Corp. · HWC Screw, Fixation, Bone

Cleared on Dec 20, 2002 after an 11-day review. The FDA summary names no predicate by number. 1 of the 858 devices in its family, counting itself, has a Class I recall. 857 later devices descend from it.

Decided
Dec 20, 2002
Review
11 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

857 later devices descend from it, 8 citing it directly. 1 of the 858 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2015: 37 descendants cleared2007: 2 descendants cleared2016: 26 descendants cleared2020: 55 descendants cleared2017: 53 descendants cleared2005: 1 descendant cleared2011: 10 descendants cleared2008: 4 descendants cleared2012: 15 descendants cleared2006: 1 descendant cleared2010: 6 descendants cleared2009: 5 descendants cleared2013: 17 descendants cleared2018: 34 descendants cleared2019: 38 descendants cleared2022: 78 descendants cleared2024: 96 descendants cleared2023: 95 descendants cleared2025: 91 descendants cleared2014: 29 descendants cleared2021: 69 descendants cleared, 1 with a Class I recall12026: 95 descendants cleared200020052010201520202025
  1. This deviceK024060 Modification to Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2002
  2. Descendant · cites it directly · 836 of its ownK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
  3. Descendant · 2 generations on · 531 of its ownK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. Descendant · 2 generations on · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
  6. Descendant · 3 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011

Showing 5 of 857 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22008: 42009: 52010: 62011: 102012: 152013: 172014: 292015: 372016: 262017: 532018: 342019: 382020: 552021: 692022: 782023: 952024: 962025: 912026: 95
2005high 96 (2024) · low 1 (2005)2026

Class I recalls in this family

  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 857 · See all
  • K051296Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005 · cites it directly836descendants
  • K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · 2 generations on531descendants
  • K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
  • K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · 2 generations on245descendants
  • K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on241descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K024060Modification to Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp.2002—
+1K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005—
+2K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.20061
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
+2K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010—
+3K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200720
200840
200950
201060
2011100
2012150
2013170
2014290
2015370
2016260
2017530
2018340
2019380
2020550
2021691
2022780
2023950
2024960
2025910
2026950
FIG. 1 — Lineage of K024060, 2002–2026Source: 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.

1 device in this family has a Class I recall. 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?

The FDA summary names no predicate by number.

What descends from it? (857)

See all 857

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005836
K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738
K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735
K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209
K160617Large Screws RangeNewclip Technics20166
K172596Large Screws RangeNewclip Technics20174
K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153
K141401Easy OutFeet For Life Podiatry Center20150

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K051296 (Depuy Spine, Inc., 2005) has gone furthest, with 836 descendants of its own.

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 Asnis III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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/K024060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K024060: Modification to Asnis Iii Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024060

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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