510(k) Report

510(k) · Cleared

Cleared

Sonoma Fibula Repair System

K160069510(k) TraditionalCleared Mar 10, 201657-day reviewClass II21 CFR 888.3020

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

Sonoma Orthopedics Products, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 10, 2016 as substantially equivalent to K142945 (Sonoma Orthopedic Products, Inc., 2015) and 2 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1992. 9 later devices descend from it.

Decided
Mar 10, 2016
Review
57 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K913949 (1992). 6 ancestors in all. 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1995: 1 other ancestor2017: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedK913949 · True/Flex Humerus, Ulna & Radius Intramed Rods Sys · Applied Osteo Systems, Inc. · 1992K031438 · Acumed Small Bone Locking Rod System II · Acumed, LLC · 2003 · recalledK071944 · Acumed Small Bone Locking System II · Acumed, LLC · 2007K142945 · Sonoma Fibula Repair System · Sonoma Orthopedic Products, Inc. · 20151990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K142945 · Sonoma Fibula Repair System · Sonoma Orthopedic Products, Inc. · 2015K071944 · Acumed Small Bone Locking System II · Acumed, LLC · 2007K031438 · Acumed Small Bone Locking Rod System II · Acumed, LLC · 2003 · recalledK913949 · True/Flex Humerus, Ulna & Radius Intramed Rods Sys · Applied Osteo Systems, Inc. · 19920
  1. Root · 4 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
  2. 3 generations backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
  3. 2 generations backK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
  4. 1 generation backK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
  5. This deviceK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
  6. Descendant · cites it directly · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
  7. Descendant · 2 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
  8. Descendant · cites it directly · 3 of its ownK173656 Arthrex FibuLock NailArthrex, Inc. · 2018
  9. Descendant · 3 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
  10. Descendant · 4 generations on · 0 of its ownK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12021: 22022: 12024: 12025: 12026: 2
2017high 2 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all
  • K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · cites it directly4descendants
  • K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 2 generations on3descendants
  • K173656Arthrex FibuLock NailArthrex, Inc. · 2018 · cites it directly3descendants
  • K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 3 generations on1descendant
  • K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K913949True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc.1992—
−3K031438Acumed Small Bone Locking Rod System IIAcumed, LLC20031
−2K071944Acumed Small Bone Locking System IIAcumed, LLC2007—
−1K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc.2015—
0 (this device)K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc.2016—
+1K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC2017—
+2K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC20212
+1K173656Arthrex FibuLock NailArthrex, Inc.2018—
+3K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower2021—
+4K252961Fusion FibFix NailFusion Orthopedics USA, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202120
202210
202410
202510
202620
FIG. 1 — Lineage of K160069, 1992–2026Source: 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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? (3)

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
*K142945Sonoma Fibula Repair System
Summary page 6
…87- Orthopedic Product Code: HSB K160069 - Page 2 of 2 Predicate Devices: K142945 Sonoma Fibula Repair System K071944 Acumed Small Bone Locking Rod System II…
Sonoma Orthopedic Products, Inc.2015—
*K071944Acumed Small Bone Locking System II
Summary page 6
…age 6 === K160069 - Page 2 of 2 Predicate Devices: K142945 Sonoma Fibula Repair System K071944 Acumed Small Bone Locking Rod System II K031438 Acumed Small Bone Locking Rod System II…
Acumed, LLC2007—
*K031438Acumed Small Bone Locking Rod System II
Summary page 6
…Devices: K142945 Sonoma Fibula Repair System K071944 Acumed Small Bone Locking Rod System II K031438 Acumed Small Bone Locking Rod System II Device Description: The Sonoma Fibula Repair System includes all implants…
Acumed, LLC20031

Also cleared against K142945: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174
K173656Arthrex FibuLock NailArthrex, Inc.20183
K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260

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?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K172943 (Intrafuse, LLC, 2017) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K142945.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

Indications for use as stated in the FDA summary.

Also cleared against K142945

1 other device cites the same predicate.

  • K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017

More from Sonoma Orthopedics Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K150376Sonoma Cancellous Bone Screw and WasherSonoma Orthopedics Products, Inc. · 2015

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K160069 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160069: Sonoma Fibula Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160069

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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