510(k) Report

510(k) · Cleared

Cleared

Flex-Thread Clavicle Pin System

K163488510(k) TraditionalCleared Mar 20, 201798-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

Intrafuse, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 20, 2017 as substantially equivalent to K971783 (Synthes (Usa), 1997) and 7 other predicates after a 98-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.

Decided
Mar 20, 2017
Review
98 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
8

Its longest line of descent runs back 4 generations to K960642 (1996). 15 ancestors in all, the oldest K903258 (1990). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2010: 1 other ancestor2008: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2011: 1 other ancestor2006: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor2020: 1 descendant clearedK960642 · Nancy Nail · Landos, Inc. · 1996K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997×2: 2 generations cleared close together, K081452 (2008), K082148 (2008) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant K082148 · Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension · Synthes (Usa) · 2008K081452 · Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System · Synthes (Usa) · 2008K971783 · Synthes Elastic Intramedullary Nail (Ein) System · Synthes (Usa) · 1997K960642 · Nancy Nail · Landos, Inc. · 19960
  1. Root · 4 generations backK960642 Nancy NailLandos, Inc. · 1996
  2. 3 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. 2 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  4. 1 generation backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
  5. This deviceK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
  6. Descendant · cites it directly · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K960642Nancy NailLandos, Inc.1996—
−3K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
−2K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
−1K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—
0 (this device)K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC2017—
+1K201830ANSER Clavicle PinBAAT Medical Products B.V.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199810
199910
200410
200510
200610
200810
201010
201110
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K163488, 1996–2020Source: 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? (8)

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
*K971783Synthes Elastic Intramedullary Nail (Ein) System
Summary page 4
…proximal cross screw to further enhance stability and fixation to the lateral portion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma…
Synthes (Usa)1997—
*K053105Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap
Summary page 4
…cross screw to further enhance stability and fixation to the lateral portion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma…
Synthes (Usa)2005—
*K042135Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)
Summary page 4
…ew to further enhance stability and fixation to the lateral portion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma…
Synthes (Usa)2004—
*K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System
Summary page 4
…ther enhance stability and fixation to the lateral portion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma…
Synthes (Usa)2008—
*K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension
Summary page 4
…nce stability and fixation to the lateral portion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma…
Synthes (Usa)2008—
*K143204AOS Clavicle Intramedullary Device
Summary page 4
…ion of the clavicle. Predicate Devices: The Synthes (USA) Elastic Intramedullary Nail (K971783, K053105, K042135, K081452, K082148), AOS Clavicle Intramedullary Device (K143204) and Sonoma K163488 p.2/2 Orthopedic…
Advanced Orthopaedic Solutions, Inc.2015—
*K081832Ensplintcmx Clavicle Pin
Summary page 5
…Sonoma K163488 p.2/2 Orthopedic Products CRx Clavicle Fracture Repair Device (K081832, K100112) serve as the predicate devices. Technological Characteristics Comparison: The Flex-Thread Clavicle Pin System and its…
Sonoma Orthopedic Products, Inc.2008—
*K100112Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)
Summary page 5
…== Page 5 === K163488 p.2/2 Orthopedic Products CRx Clavicle Fracture Repair Device (K081832, K100112) serve as the predicate devices. Technological Characteristics Comparison: The Flex-Thread Clavicle Pin System and its predicate…
Sonoma Orthopedic Products, Inc.2010—

Also cleared against K971783: 12 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K201830ANSER Clavicle PinBAAT Medical Products B.V.20200

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 21 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • Of its descendants, K201830 (BAAT Medical Products B.V., 2020) has gone furthest, with 0 descendants of its own.
  • 12 other devices also cite its predicate K971783.

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. 2017, 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 Flex-Thread Clavicle Pin System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Indications for use as stated in the FDA summary.

Also cleared against K971783

12 other devices cite the same predicate.

  • K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
  • K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited · 2022
  • K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
  • K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
  • K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015

More from Intrafuse, LLC

2 FDA decisions under this applicant name. See the company

  • K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017

Recent decisions in HSB

The HSB category page

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  • 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/K163488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163488: Flex-Thread Clavicle Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163488

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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