510(k) Report

510(k) · Cleared

Cleared

Synthes 2.4 MM Cannulated Compression Screw

K021556510(k) TraditionalCleared Aug 9, 200288-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

Synthes (Usa) · HWC Screw, Fixation, Bone

Cleared on Aug 9, 2002 after an 88-day review. The FDA summary names its predicate without a number. 80 later devices descend from it.

Decided
Aug 9, 2002
Review
88 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

80 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2015: 4 descendants cleared2011: 2 descendants cleared2004: 1 descendant cleared2019: 2 descendants cleared2017: 3 descendants cleared2016: 6 descendants cleared2018: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2020: 6 descendants cleared2023: 8 descendants cleared2022: 10 descendants cleared2021: 3 descendants cleared2026: 14 descendants cleared2025: 6 descendants cleared2024: 9 descendants cleared200020052010201520202025
  1. This deviceK021556 Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa) · 2002
  2. Descendant · cites it directly · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
  3. Descendant · cites it directly · 23 of its ownK133842 Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
  4. Descendant · 2 generations on · 12 of its ownK153575 Tyber Medical Trauma ScrewTyber Medical, LLC · 2016
  5. Descendant · cites it directly · 12 of its ownK112737 Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011 · Recalled
  6. Descendant · cites it directly · 12 of its ownK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12011: 22013: 12014: 22015: 42016: 62017: 32018: 22019: 22020: 62021: 32022: 102023: 82024: 92025: 62026: 14
2004high 14 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 80 · See all
  • K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · cites it directly33descendants
  • K133842Tyber Medical Trauma ScrewTyber Medical, LLC · 2014 · cites it directly23descendants
  • K153575Tyber Medical Trauma ScrewTyber Medical, LLC · 2016 · 2 generations on12descendants
  • K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011 · cites it directly12descendants
  • K110658Aptus Cannulated Compression ScrewsMedartis AG · 2011 · cites it directly12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021556Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa)2002—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…Synthes USA Products, LLC2017—
+1K133842Tyber Medical Trauma ScrewTyber Medical, LLC2014—
+2K153575Tyber Medical Trauma ScrewTyber Medical, LLC2016—
+1K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd.20114
+1K110658Aptus Cannulated Compression ScrewsMedartis AG2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201120
201310
201420
201540
201660
201730
201820
201920
202060
202130
2022100
202380
202490
202560
2026140
FIG. 1 — Lineage of K021556, 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.

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? (1)

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
*—Synthes 2.4 mm Cannulated Screw
Named without a submission number
—

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733
K133842Tyber Medical Trauma ScrewTyber Medical, LLC201423
K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd.201112
K110658Aptus Cannulated Compression ScrewsMedartis AG201112
K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.20167
K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Zimmer, Inc.20157
K190830TDM Screw SystemsTdm Co., Ltd.20191
K040265Little Grafter ScrewBiocomposites, Ltd.20041
K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH20180
K140216Orthopedic Fixation SystemsImpact Medical, LLC20140

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?

  • Of its descendants, K161616 (Synthes USA Products, LLC, 2017) has gone furthest, with 33 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?

Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K021556 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021556: Synthes 2.4 MM Cannulated Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021556

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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