510(k) Report

510(k) · Cleared

Cleared

Sbi Hand Fixation System (TM)

K050462510(k) TraditionalCleared Apr 26, 200562-day reviewClass II21 CFR 888.3030

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 · HRS Plate, Fixation, Bone

Cleared on Apr 26, 2005 after a 62-day review. The FDA summary names no predicate by number. 102 later devices descend from it.

Decided
Apr 26, 2005
Review
62 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

102 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2009: 1 descendant cleared2020: 12 descendants cleared2014: 3 descendants cleared2011: 2 descendants cleared2012: 4 descendants cleared2024: 11 descendants cleared2026: 10 descendants cleared2023: 7 descendants cleared2017: 11 descendants cleared2013: 3 descendants cleared2015: 4 descendants cleared2019: 8 descendants cleared2016: 4 descendants cleared2018: 5 descendants cleared2022: 4 descendants cleared2025: 4 descendants cleared2021: 8 descendants cleared20052010201520202025
  1. This deviceK050462 Sbi Hand Fixation System (TM)Small Bone Innovations, LLC · 2005
  2. Descendant · cites it directly · 85 of its ownK101962 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 77 of its ownK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
  4. Descendant · 2 generations on · 64 of its ownK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  5. Descendant · 3 generations on · 38 of its ownK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
  6. Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 22012: 42013: 32014: 32015: 42016: 42017: 112018: 52019: 82020: 122021: 82022: 42023: 72024: 112025: 42026: 10
2009high 12 (2020) · low 1 (2009)2026

Most influential descendants

Showing 5 of 102 · See all
  • K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2010 · cites it directly85descendants
  • K111041Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011 · 2 generations on77descendants
  • K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 2 generations on64descendants
  • K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012 · 3 generations on38descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050462Sbi Hand Fixation System (TM)Small Bone Innovations, LLC2005—
+1K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.20101
+2K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.2011—
+2K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
+3K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2012—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 282014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201120
201240
201330
201430
201540
201640
2017110
201850
201980
2020120
202180
202240
202370
2024110
202540
2026100
FIG. 1 — Lineage of K050462, 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (102)

See all 102

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

NumberDeviceApplicantDecidedDescendants
K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201085
K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915

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, K101962 (Orthohelix Surgical Designs, Inc., 2010) has gone furthest, with 85 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The SBI Hand Fixation System TM is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other 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

  • K052576Sbi AutofixSmall Bone Innovations, LLC · 20051 recall
  • K051747Sbi WristfitSmall Bone Innovations, LLC · 2005
  • K051605Sbi K-WiresSmall Bone Innovations, LLC · 2005

Recent decisions in HRS

The HRS category page

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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K050462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050462: Sbi Hand Fixation System (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050462

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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