510(k) Report

510(k) · Cleared

Cleared

ExsoMed ITN Cannulated Screw System

K171558510(k) TraditionalCleared Sep 1, 201794-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

Exsomed Holdings Company, LLC · HWC Screw, Fixation, Bone

Cleared on Sep 1, 2017 as substantially equivalent to K050636 (Synthes (Usa), 2005) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided
Sep 1, 2017
Review
94 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K000080 (2000). 2 ancestors in all. 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2019: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedReference device: K171407 · ExsoMed ArcPhix and ExsoMed ArrowPhix · Exsomed Holding Company, LLC · 2017K000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants K000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalled0
  1. Root · 1 generation backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
  2. This deviceK171558 ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC · 2017
  3. Descendant · cites it directly · 5 of its ownK183603 INnate Cannulated Screw SystemExsomed Corporation · 2019
  4. Descendant · cites it directly · 1 of its ownK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
  5. Descendant · cites it directly · 0 of its ownK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
  6. Descendant · 2 generations on · 0 of its ownK252312 Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4 · 2025
  7. Descendant · 2 generations on · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2019: 12020: 12022: 12023: 22025: 12026: 1
2019high 2 (2023) · low 0 (2021)2026

Most influential descendants

Showing 5 of 7 · See all
  • K183603INnate Cannulated Screw SystemExsomed Corporation · 2019 · cites it directly5descendants
  • K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020 · cites it directly1descendant
  • K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026 · cites it directly0descendants
  • K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4 · 2025 · 2 generations on0descendants
  • K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000080Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp.20001
0 (this device)K171558ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC2017—
+1K183603INnate Cannulated Screw SystemExsomed Corporation2019—
+1K201430InFrame™ Cannulated Fixation SystemExsomed Corp.2020—
+1K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026—
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev42025—
+2K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202010
202210
202320
202510
202610
FIG. 1 — Lineage of K171558, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K050636Synthes 3.0MM Headless Compression Screws
Summary page 5
….0MM HEADLESS COMPRESSION SCREWS Common Name: Screw, Fixation, Bone Manufacturer: SYNTHES (USA) K Number: K050636 Clearance Date: 04/21/2005 Secondary Predicate: ASNIS III CANNULATED SCREW…
Synthes (Usa)20051
*K000080Asnis Iii Cannulated Screw System
Summary page 5
…NULATED SCREW SYSTEM Common Name: Screw, Fixation, Bone Manufacturer: HOWMEDICA OSTEONICS CORP. K Number: K000080 Clearance Date: April 3, 2000 Reference Predicate: ExsoMed™ SMALL BONE SCREW…
Howmedica Osteonics Corp.20001
†K171407ExsoMed ArcPhix and ExsoMed ArrowPhixExsomed Holding Company, LLC2017—

Also cleared against K050636: 18 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K183603INnate Cannulated Screw SystemExsomed Corporation20195
K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260
K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230

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 2 ancestors have a recall of any class.
  • Of its descendants, K183603 (Exsomed Corporation, 2019) has gone furthest, with 5 descendants of its own.
  • 18 other devices also cite its predicate K050636.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ExsoMed ITN Cannulated Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Indications for use as stated in the FDA summary.

Also cleared against K050636

18 other devices cite the same predicate.

  • K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
  • K191771SECURE ScrewA.M. Surgical, Inc. · 2019
  • K190830TDM Screw SystemsTdm Co., Ltd. · 2019
  • K183603INnate Cannulated Screw SystemExsomed Corporation · 2019
  • K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH · 2018
  • K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017

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/K171558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171558: ExsoMed ITN Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171558

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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