510(k) Report

510(k) · Cleared

Cleared

Ascension Cannulated Screw System

K092440510(k) TraditionalCleared Nov 5, 200987-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

Ascension Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 5, 2009 as substantially equivalent to K991151 (Vilex, Inc., 1999) and 4 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1989.

Decided
Nov 5, 2009
Review
87 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K893512 (1989). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1996: 1 other ancestor1990: 1 other ancestorK893512 · Depuy Cannulated Bone Screw · Depuy, Inc. · 1989198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors K893512 · Depuy Cannulated Bone Screw · Depuy, Inc. · 19890
  1. Root · 1 generation backK893512 Depuy Cannulated Bone ScrewDepuy, Inc. · 1989
  2. This deviceK092440 Ascension Cannulated Screw SystemAscension Orthopedics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K893512Depuy Cannulated Bone ScrewDepuy, Inc.1989—
0 (this device)K092440Ascension Cannulated Screw SystemAscension Orthopedics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199610
199920
FIG. 1 — Lineage of K092440, 1989–2009Source: 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 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
*K991151Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw
Summary page 1
…ne Screws CLASSIFICATION: 21 CFR 888.3040 - Bone Fixation Screw PRODUCT CODE: HWC PANEL: Orthopedic PREDICATE DEVICES: K991151 and K991 197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith…
Vilex, Inc.1999—
*K991197Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…
Summary page 1
…LASSIFICATION: 21 CFR 888.3040 - Bone Fixation Screw PRODUCT CODE: HWC PANEL: Orthopedic PREDICATE DEVICES: K991151 and K991 197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cann…
Vilex, Inc.1999—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…88.3040 - Bone Fixation Screw PRODUCT CODE: HWC PANEL: Orthopedic PREDICATE DEVICES: K991151 and K991 197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cannulated Interference Screw System…
Synthes (Usa)1996—
*K893512Depuy Cannulated Bone Screw
Summary page 1
…CT CODE: HWC PANEL: Orthopedic PREDICATE DEVICES: K991151 and K991 197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cannulated Interference Screw System DEVICE DESCRIPTION: The Ascension® C…
Depuy, Inc.1989—
*K901616Cannulated Interference Screw System
Summary page 1
…Orthopedic PREDICATE DEVICES: K991151 and K991 197 - Vilex Cannulated Screws K962823 - Synthes Cannulated Screws K893512 - DePuy Cannulated Bone Screw K901616 - Smith & Nephew Cannulated Interference Screw System DEVICE DESCRIPTION: The Ascension® Cannulated Screw System consists of var…
Smith & Nephew Dyonics, Inc.1990—

Also cleared against K991151: 9 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 5 ancestors has a recall.
  • 9 other devices also cite its predicate K991151.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

The Ascension Cannulated Screw System is intended for the following:

Fixation of fractures in long bones

Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow

Arthrodesis of the foot, wrist and elbow

Small and long bone osteotomies

Indications for use as stated in the FDA summary.

Also cleared against K991151

9 other devices cite the same predicate.

  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K171690Trident Extremity Fixation SystemTrident Orthopedics · 2018
  • K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
  • K124027Monster Screw SystemApogee Orthosolutions · 2013
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K091798Merete Compression ScrewsMerete Medical GmbH · 2009

More from Ascension Orthopedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  • K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
  • K121826Integra Proximal Humeral Plate SystemAscension Orthopedics, Inc. · 2013
  • K110700Ascension Atlas Humeral Plating SystemAscension Orthopedics, Inc. · 2011
  • K102549The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 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/K092440 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092440: Ascension 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/K092440

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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