510(k) Report

510(k) · Cleared

Cleared

Arthrex Bio-Compression Screw

K060478510(k) TraditionalCleared May 19, 200685-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 May 19, 2006 after an 85-day review. The FDA summary names no predicate by number. 27 later devices descend from it.

Decided
May 19, 2006
Review
85 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

27 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2026: 4 descendants cleared2020: 2 descendants cleared2013: 1 descendant cleared2017: 4 descendants cleared2018: 1 descendant cleared2025: 2 descendants cleared2015: 1 descendant cleared2022: 4 descendants cleared2024: 2 descendants cleared2023: 3 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared20052010201520202025
  1. This deviceK060478 Arthrex Bio-Compression ScrewArthrex, Inc. · 2006
  2. Descendant · cites it directly · 18 of its ownK132217 Arthrex Compression FT ScrewsArthrex, Inc. · 2013
  3. Descendant · cites it directly · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
  4. Descendant · 2 generations on · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
  5. Descendant · 2 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022
  6. Descendant · 2 generations on · 4 of its ownK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12017: 42018: 12019: 12020: 22021: 22022: 42023: 32024: 22025: 22026: 4
2013high 4 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 27 · See all
  • K132217Arthrex Compression FT ScrewsArthrex, Inc. · 2013 · cites it directly18descendants
  • K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · cites it directly6descendants
  • K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · 2 generations on6descendants
  • K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 2 generations on4descendants
  • K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060478Arthrex Bio-Compression ScrewArthrex, Inc.2006—
+1K132217Arthrex Compression FT ScrewsArthrex, Inc.2013—
+1K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.2020—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.2015—
+2K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.2022—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201740
201810
201910
202020
202120
202240
202330
202420
202520
202640
FIG. 1 — Lineage of K060478, 2006–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K132217Arthrex Compression FT ScrewsArthrex, Inc.201318
K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206
K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260

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, K132217 (Arthrex, Inc., 2013) has gone furthest, with 18 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 Blo-Compression Screw is intended for fixation of fractures, osteotomies and arthrodesis in:

* Carpal, metacarpal, and small hand bone

* tarsal and metatarsals

* phalanges

Intra-articular fractures

* ankle

* proximal and distal humerus

* proximal and distal radius

* proximal and distal ulna

* osteochondral fixation and fractures.

Osteochondritis Dissecans

* Fixation of fractures and osteotomies about the knee

* Oblique fractures of the fi'bula

* Reconstructive surgeries of the fool:

* malleolar fixation

where size of offered implant is patient appropriate.

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

  • 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/K060478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060478: Arthrex Bio-Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060478

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