510(k) Report

510(k) · Cleared

Cleared

Sbi K-Wires

K051605510(k) TraditionalCleared Aug 10, 200555-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, LLC · HTY Pin, Fixation, Smooth

Cleared on Aug 10, 2005 after a 55-day review. The FDA summary names no predicate by number. 27 later devices descend from it.

Decided
Aug 10, 2005
Review
55 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

27 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2017: 4 descendants cleared2020: 2 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2018: 2 descendants cleared2014: 2 descendants cleared2016: 2 descendants cleared2021: 3 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK051605 Sbi K-WiresSmall Bone Innovations, LLC · 2005
  2. Descendant · cites it directly · 12 of its ownK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
  3. Descendant · 2 generations on · 10 of its ownK133691 Extrimilock Ankle Plating SystemOsteomed LP · 2014
  4. Descendant · cites it directly · 9 of its ownK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
  5. Descendant · 3 generations on · 5 of its ownK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
  6. Descendant · 2 generations on · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22014: 22015: 12016: 22017: 42018: 22020: 22021: 32022: 12023: 12024: 12025: 22026: 2
2012high 4 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 27 · See all
  • K120787Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012 · cites it directly12descendants
  • K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014 · 2 generations on10descendants
  • K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets · 2012 · cites it directly9descendants
  • K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016 · 3 generations on5descendants
  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051605Sbi K-WiresSmall Bone Innovations, LLC2005—
+1K120787Merete Locking Bone Plate System IiiMerete Medical GmbH2012—
+2K133691Extrimilock Ankle Plating SystemOsteomed LP2014—
+1K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical…Medical Facets2012—
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC2016—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201320
201420
201510
201620
201740
201820
202020
202130
202210
202310
202410
202520
202620
FIG. 1 — Lineage of K051605, 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 HTY? 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 HTY device

  1. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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

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

NumberDeviceApplicantDecidedDescendants
K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212
K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129
K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.20200
K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170
K141401Easy OutFeet For Life Podiatry Center20150
K122777NBX - Non Bridging External Fixator HandNutek Orthopaedics, Inc.20130

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, K120787 (Merete Medical GmbH, 2012) has gone furthest, with 12 descendants of its own.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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

  • K052576Sbi AutofixSmall Bone Innovations, LLC · 20051 recall
  • K051747Sbi WristfitSmall Bone Innovations, LLC · 2005
  • K050462Sbi Hand Fixation System (TM)Small Bone Innovations, LLC · 2005

Recent decisions in HTY

The HTY category page

  • K262126Cerclage Wires;K-wires;Steinmann PinsMK Medical GmbH · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250315Ronavis – FX (FX-001)AIRS, Inc. · 2025

https://510kreport.com/device/K051605 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051605: Sbi K-Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051605

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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