510(k) Report

510(k) · Cleared

Cleared

Smartscrew Model 222006...227510

K003077510(k) TraditionalCleared Apr 26, 2001205-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

Bionx Implants, Ltd. · HWC Screw, Fixation, Bone

Cleared on Apr 26, 2001 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 342 later devices descend from it.

Decided
Apr 26, 2001
Review
205 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2006: 4 descendants cleared2005: 6 descendants cleared2008: 6 descendants cleared2002: 1 descendant cleared2004: 2 descendants cleared2003: 1 descendant cleared2013: 9 descendants cleared2015: 10 descendants cleared2018: 16 descendants cleared2019: 28 descendants cleared2017: 15 descendants cleared2011: 5 descendants cleared2020: 25 descendants cleared2024: 37 descendants cleared2025: 31 descendants cleared2014: 18 descendants cleared2021: 24 descendants cleared2012: 3 descendants cleared2022: 24 descendants cleared2026: 36 descendants cleared2016: 7 descendants cleared2023: 28 descendants cleared2007: 2 descendants cleared2009: 3 descendants cleared200020052010201520202025
  1. This deviceK003077 Smartscrew Model 222006...227510Bionx Implants, Ltd. · 2001
  2. Descendant · cites it directly · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
  3. Descendant · cites it directly · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
  4. Descendant · cites it directly · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  5. Descendant · 2 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  6. Descendant · 2 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled

Showing 5 of 342 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 22005: 62006: 42007: 22008: 62009: 32011: 52012: 32013: 92014: 182015: 102016: 72017: 152018: 162019: 282020: 252021: 242022: 242023: 282024: 372025: 312026: 36
2001high 37 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 342 · See all
  • K012001SmartscrewBionx Implants, Ltd. · 2001 · cites it directly337descendants
  • K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · cites it directly333descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · cites it directly306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 2 generations on217descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 2 generations on94descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003077Smartscrew Model 222006...227510Bionx Implants, Ltd.2001—
+1K012001SmartscrewBionx Implants, Ltd.2001—
+1K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003—
+1K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+2K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+2K083070Toggleloc SystemBiomet Sports Medicine20086

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200420
200560
200640
200720
200860
200930
201150
201230
201390
2014180
2015100
201670
2017150
2018160
2019280
2020250
2021240
2022240
2023280
2024370
2025310
2026360
FIG. 1 — Lineage of K003077, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (342)

See all 342

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

NumberDeviceApplicantDecidedDescendants
K012001SmartscrewBionx Implants, Ltd.2001337
K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306
K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd.200519
K023022Nugen FX ScrewBionx Implants, Inc.20022
K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041
K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080
K061763Arc Surgical Biotrak ScrewArc Surgical, LLC20060
K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050
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, K012001 (Bionx Implants, Ltd., 2001) has gone furthest, with 337 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—

More from Bionx Implants, Ltd.

12 FDA decisions under this applicant name. See the company

  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002
  • K0120001.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
  • K012001SmartscrewBionx Implants, Ltd. · 2001
  • K003757Thermofx MeshBionx Implants, Ltd. · 2001

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/K003077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003077: Smartscrew Model 222006...227510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003077

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026