510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Sbi Autofix

K052576510(k) TraditionalCleared Nov 7, 200549-day reviewClass II21 CFR 888.3040Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Small Bone Innovations, LLC · HWC Screw, Fixation, Bone

Cleared on Nov 7, 2005 after a 49-day review. The FDA summary names no predicate by number. 28 later devices descend from it. It has been recalled once.

Decided
Nov 7, 2005
Review
49 days
Class
Class II
Product code
HWC
Recalls
1
Predicates
0

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

Descendants, by year cleared 2018: 1 descendant cleared2016: 2 descendants cleared2017: 5 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2023: 5 descendants cleared2026: 4 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK052576 Sbi AutofixSmall Bone Innovations, LLC · 2005
  2. Descendant · cites it directly · 18 of its ownK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled
  3. Descendant · cites it directly · 17 of its ownK160174 I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016
  4. Descendant · 2 generations on · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
  5. Descendant · cites it directly · 7 of its ownK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
  6. Descendant · 3 generations on · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2014: 12015: 22016: 22017: 52018: 12019: 22020: 32021: 22023: 52025: 12026: 4
2014high 5 (2017) · low 0 (2022)2026

Most influential descendants

Showing 5 of 28 · See all
  • K131920Stabilization ScrewIn2bones Sas · 2014 · cites it directly18descendants
  • K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas · 2016 · cites it directly17descendants
  • K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · 2 generations on15descendants
  • K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · cites it directly7descendants
  • K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052576Sbi AutofixSmall Bone Innovations, LLC2005—
+1K131920Stabilization ScrewIn2bones Sas20143
+1K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas2016—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC20171
+1K180377Fracture and Correction SystemIn2bones USA, LLC2018—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201520
201620
201750
201810
201920
202030
202120
202350
202510
202640
FIG. 1 — Lineage of K052576, 2005–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K131920Stabilization ScrewIn2bones Sas201418
K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617
K180377Fracture and Correction SystemIn2bones USA, LLC20187
K143229Nexis osteosynthesis compressive screwsNovastep20153
K170594I.B.S. osteosynthesis screwsIn2bones Sas20171
K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie20170
K171407ExsoMed ArcPhix and ExsoMed ArrowPhixExsomed Holding Company, LLC20170
K170012Foot and Hand MotionNewclip Technics20170
K143596Miniars ScrewsOvermed Srl.20160
K150871ForeFoot STP SystemTornier, Inc.20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 19, 2014Class IIZ-2127-2014Process controlSmall Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131920 (In2bones Sas, 2014) 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 SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.

Indications for use as stated in the FDA summary.

More from Small Bone Innovations, LLC

4 FDA decisions under this applicant name. See the company

  • K051747Sbi WristfitSmall Bone Innovations, LLC · 2005
  • K051605Sbi K-WiresSmall Bone Innovations, LLC · 2005
  • K050462Sbi Hand Fixation System (TM)Small Bone Innovations, LLC · 2005

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/K052576 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052576: Sbi Autofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052576

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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