510(k) Report

510(k) · Cleared

Cleared

Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models AR-5024B, AR-5025B

K032098510(k) TraditionalCleared Oct 7, 200391-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

Arthrex, Inc. · HWC Screw, Fixation, Bone

Cleared on Oct 7, 2003 after a 91-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Oct 7, 2003
Review
91 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2005: 1 descendant cleared200020052010201520202025
  1. This deviceK032098 Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw…Arthrex, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK061763 Arc Surgical Biotrak ScrewArc Surgical, LLC · 2006 · Recalled
  3. Descendant · cites it directly · 0 of its ownK043176 Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K061763Arc Surgical Biotrak ScrewArc Surgical, LLC · 2006 · cites it directly0descendants
  • K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032098Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large…Arthrex, Inc.2003—
+1K061763Arc Surgical Biotrak ScrewArc Surgical, LLC20061
+1K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K032098, 2003–2006Source: 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?

The FDA summary names no predicate by number.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K061763Arc Surgical Biotrak ScrewArc Surgical, LLC20060
K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC20050

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, K061763 (Arc Surgical, LLC, 2006) has gone furthest, with 0 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 Arthrex Bio-Compression Screw is a bioabsorbable polylactide (PLLA) screw intended to provide fixation of small bone fragments such as apical fragments, osteochondral fragments, and cancellous fragments. Specifically;

Apical Fragments: Radial Head, Patellar Rim, Navicular, Metacarpal and Metatarsal

Osteochondral Fragments: Talar Vault, femoral condyle

Cancellous Fragments: Talus

Indications for use as stated in the FDA summary.

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in HWC

The HWC category page

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  • 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/K032098 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032098: Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models AR-5024B, AR-5025B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032098

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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