510(k) Report

510(k) · Cleared

Cleared

Sbi Foot and Ankle Cannulated Screw System, Model 100-0061

K092754510(k) TraditionalCleared Jan 19, 2010132-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

Small Bone Innovations, Inc. · HWC Screw, Fixation, Bone

Cleared on Jan 19, 2010 as substantially equivalent to K962011 (Synthes (Usa), 1996) and 4 other predicates after a 132-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.

Decided
Jan 19, 2010
Review
132 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K962011 (1996). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor2017: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants K962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19960
  1. Root · 1 generation backK962011 Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa) · 1996
  2. This deviceK092754 Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc. · 2010
  3. Descendant · cites it directly · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
  4. Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  5. Descendant · 3 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
  6. Descendant · 3 generations on · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026

Most influential descendants

Showing 4 of 4 · See all
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · cites it directly3descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
  • K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 3 generations on0descendants
  • K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962011Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa)1996—
0 (this device)K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc.2010—
+1K161894SurgTech Trauma SystemSurgtech, Inc.2017—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System…Ortler Global Tibbi Gerecler Anonim Sirketi2026—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202410
202620
FIG. 1 — Lineage of K092754, 1996–2026Source: 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? (5)

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
*K962011Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 2
…de the appropriate size washers of the same material. Predicate Devices: The subject devices are equivalent to Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K(96201 1, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mmn Cannuilated Screws (K983006, K000080). === Page 3…
Synthes (Usa)20027
*K052483Synthes (Usa) Spherical Washers
Summary page 2
…propriate size washers of the same material. Predicate Devices: The subject devices are equivalent to Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K(96201 1, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mmn Cannuilated Screws (K983006, K000080).…
Synthes (Usa)2005—
*K983006Osteo 5.0MM Cannulated Screw System
Summary page 2
…t to Synthes 6.5mm and 7.0/7.3mm Cannulated Screws (K(96201 1, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mmn Cannuilated Screws (K983006, K000080). "4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public H…
Stryker Osteonics1998—
*K000080Asnis Iii Cannulated Screw System
Summary page 2
…hes 6.5mm and 7.0/7.3mm Cannulated Screws (K(96201 1, K021932, K052483) and Howmedica Osteonics (Stryker) Asnis III 5.0mm, 6.5mm, and 8.0mmn Cannuilated Screws (K983006, K000080). "4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser…
Howmedica Osteonics Corp.20001

Also cleared against K962011: 26 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161894SurgTech Trauma SystemSurgtech, Inc.20173

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 5 ancestors have a recall of any class.
  • Of its descendants, K161894 (Surgtech, Inc., 2017) has gone furthest, with 3 descendants of its own.
  • 26 other devices also cite its predicate K962011.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis;, pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

Also cleared against K962011

26 other devices cite the same predicate.

  • K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company · 2022
  • K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2019
  • K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd. · 2018
  • K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017

More from Small Bone Innovations, Inc.

20 FDA decisions under this applicant name. See the company

  • K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
  • K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012
  • K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 20109 recalls
  • K093550Mini Rail External Fixator SystemSmall Bone Innovations, Inc. · 2010
  • K073635Sbi SR MTP Toe ImplantSmall Bone Innovations, Inc. · 2008

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/K092754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092754: Sbi Foot and Ankle Cannulated Screw System, Model 100-0061.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092754

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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