510(k) Report

510(k) · Cleared

Cleared

ARBOR External Fixation System

K172438510(k) TraditionalCleared Jan 12, 2018154-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

Globus Medical, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 12, 2018 as substantially equivalent to K031428 (Synthes (Usa), 2003) and 6 other predicates after a 154-day review. Its family tree reaches back 3 generations to 1986.

Decided
Jan 12, 2018
Review
154 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K861766 (1986). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2012: 2 other ancestors2006: 2 other ancestors2005: 3 other ancestors2004: 1 other ancestor2003: 1 other ancestor1988: 1 other ancestorK861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 1986K964094 · Minifix · Ferguson Medical · 1996K093550 · Mini Rail External Fixator System · Small Bone Innovations, Inc. · 201019851990199520002005201020152020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors K093550 · Mini Rail External Fixator System · Small Bone Innovations, Inc. · 2010K964094 · Minifix · Ferguson Medical · 1996K861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 19860
  1. Root · 3 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
  2. 2 generations backK964094 MinifixFerguson Medical · 1996
  3. 1 generation backK093550 Mini Rail External Fixator SystemSmall Bone Innovations, Inc. · 2010
  4. This deviceK172438 ARBOR External Fixation SystemGlobus Medical, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861766Howmedica Hoffmann Fixation Pin SystemHowmedica Corp.1986—
−2K964094MinifixFerguson Medical1996—
−1K093550Mini Rail External Fixator SystemSmall Bone Innovations, Inc.2010—
0 (this device)K172438ARBOR External Fixation SystemGlobus Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
200310
200410
200530
200620
201220
201610
FIG. 1 — Lineage of K172438, 1986–2018Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 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? (7)

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
*K031428Synthes (Usa) Large External Fixation Clamps-MR Safe
Summary page 4
…essories Product Codes: KTT, LXT Regulatory Class: II, Panel Code: 87 Primary Predicate: Synthes Large External Fixation System (K031428) Additional Gexfix External Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation Sys…
Synthes (Usa)20031
*K052605External Fixation
Summary page 4
…Regulatory Class: II, Panel Code: 87 Primary Predicate: Synthes Large External Fixation System (K031428) Additional Gexfix External Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation System (K093550) Stryker Hoffmann 3 (K122284)…
Gexfix USA, Inc.2005—
*K160972Gexfix External Fixation
Summary page 4
…Regulatory Class: II, Panel Code: 87 Primary Predicate: Synthes Large External Fixation System (K031428) Additional Gexfix External Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation System (K093550) Stryker Hoffmann 3 (K122284) & Apex Pin…
Gexfix International Corp.2016—
*K093550Mini Rail External Fixator System
Summary page 4
…e External Fixation System (K031428) Additional Gexfix External Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation System (K093550) Stryker Hoffmann 3 (K122284) & Apex Pins (K061493) Synthes Medium External Fixation Syst…
Small Bone Innovations, Inc.2010—
*K122284Hoffmann 3
Summary page 4
…Gexfix External Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation System (K093550) Stryker Hoffmann 3 (K122284) & Apex Pins (K061493) Synthes Medium External Fixation System (K040258) Purpose: The purpose of this submis…
Stryker Corp.2012—
*K061493Apex Pins
Summary page 4
…al Fixation System (K052605 & K160972) Predicates: SBi Mini Rail External Fixation System (K093550) Stryker Hoffmann 3 (K122284) & Apex Pins (K061493) Synthes Medium External Fixation System (K040258) Purpose: The purpose of this submission is to request cle…
Stryker Howmedica Osteonics2006—
*K040258Synthes Medium External Fixation System-MR Safe
Summary page 4
…il External Fixation System (K093550) Stryker Hoffmann 3 (K122284) & Apex Pins (K061493) Synthes Medium External Fixation System (K040258) Purpose: The purpose of this submission is to request clearance for the ARBOR™ External Fixation System. Device Description: T…
Synthes (Usa)2004—

Also cleared against K031428: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 32 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K031428.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The ARBOR™ External Fixation System is indicated for use in construction of an external fixation frame for the treatment of pediatric and adult fractures and/or reconstruction of long bones, small bones (including metacarpal and metatarsal), and the pelvis. The ARBOR™ External Fixation System is intended for: • Stabilization of open or closed fractures with soft tissue injuries; • Polytrauma; • Vertically stable pelvic fractures or as a treatment adjunct…

Read the full statement (131 words)

The ARBOR™ External Fixation System is indicated for use in construction of an external fixation frame for the treatment of pediatric and adult fractures and/or reconstruction of long bones, small bones (including metacarpal and metatarsal), and the pelvis.

The ARBOR™ External Fixation System is intended for:

• Stabilization of open or closed fractures with soft tissue injuries;

• Polytrauma;

• Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;

• Arthrodesis and osteotomies with soft tissue problems;

• Revision procedures where other devices have been unsuccessful including failures of total joints;

• Neutralization of fractures stabilized with limited internal fixation;

• Non-unions/septic non-unions;

• Intraoperative reduction/stabilization tool to assist with indirect reduction;

• Correction of deformity; and

• Unilateral rectilinear bone segment transport or leg lengthening.

Indications for use as stated in the FDA summary.

Also cleared against K031428

5 other devices cite the same predicate.

  • K171211OIC External Fixation SystemOrthopaedic Implant Company · 2017
  • K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 20132 recalls
  • K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012
  • K091258Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
  • K051957Reprocessed External Fixation DeviceSterilemed, Inc. · 20051 recall

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K172438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172438: ARBOR External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172438

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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