510(k) Report

510(k) · Cleared

Cleared

Small Bone Nail Implant

K151456510(k) TraditionalCleared Oct 29, 2015150-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

Vilex IN Tennessee, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Oct 29, 2015 as substantially equivalent to K031438 (Acumed, LLC, 2003) and 5 other predicates after a 150-day review. Its family tree reaches back 6 generations to 2000.

Decided
Oct 29, 2015
Review
150 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K000684 (2000). 21 ancestors in all, the oldest K854338 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2003: 1 other ancestor1998: 2 other ancestors1985: 1 other ancestor1995: 2 other ancestors1992: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor2001: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestorK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K021626 · Hallu Plates · New Deal, S.A. · 2002K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 20051985199019952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 5 other ancestors K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K021626 · Hallu Plates · New Deal, S.A. · 2002K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50
  1. Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 3 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
  5. 2 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  6. 1 generation backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
  7. This deviceK151456 Small Bone Nail ImplantVilex IN Tennessee, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−5K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−4K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−3K021626Hallu PlatesNew Deal, S.A.2002—
−2K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—
−1K052614Low Profile Plate and Screw SystemArthrex, Inc.2005—
0 (this device)K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199110
199210
199410
199520
199610
199820
200010
200110
200210
200310
200710
FIG. 1 — Lineage of K151456, 2000–2015Source: 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
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What was it cleared against? (6)

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
*K031438Acumed Small Bone Locking Rod System II
Summary page 4
…, Fixation, Intramedullary And Accessories Name: Device Class: Class II Product Code: HSB/ Orthopedics Predicate Acumed Small Bone Locking Rod System (K031438 and K071944) Biomet Titanium Intramedullary Rods-Various Styles (K982953) and Devices: Kirsch…
Acumed, LLC20031
*K071944Acumed Small Bone Locking System II
Summary page 4
…Intramedullary And Accessories Name: Device Class: Class II Product Code: HSB/ Orthopedics Predicate Acumed Small Bone Locking Rod System (K031438 and K071944) Biomet Titanium Intramedullary Rods-Various Styles (K982953) and Devices: Kirschner (now Bio…
Acumed, LLC2007—
*K982953Titanium Intramedullary Nails-Various Styles
Summary page 4
…HSB/ Orthopedics Predicate Acumed Small Bone Locking Rod System (K031438 and K071944) Biomet Titanium Intramedullary Rods-Various Styles (K982953) and Devices: Kirschner (now Biomet, Inc.) Intramedullary Nail System (K854338) Arthrex Openi…
Biomet, Inc.19984
*K854338Kirschner Intramedullary Nail System
Summary page 4
…4) Biomet Titanium Intramedullary Rods-Various Styles (K982953) and Devices: Kirschner (now Biomet, Inc.) Intramedullary Nail System (K854338) Arthrex Opening Wedge Osteotomy System (K973812) Arthrex Low Profile Plate and Screw System…
Kirschner Medical Corp.1985—
*K973812Arthrex Puddu Osteotomy System
Summary page 4
…yles (K982953) and Devices: Kirschner (now Biomet, Inc.) Intramedullary Nail System (K854338) Arthrex Opening Wedge Osteotomy System (K973812) Arthrex Low Profile Plate and Screw System (K052614) Description of The Vilex Small Bone Nail Implant Syst…
Arthrex, Inc.1998—
*K052614Low Profile Plate and Screw System
Summary page 4
…c.) Intramedullary Nail System (K854338) Arthrex Opening Wedge Osteotomy System (K973812) Arthrex Low Profile Plate and Screw System (K052614) Description of The Vilex Small Bone Nail Implant System includes Tapered Nails (straight Device: or bowed) and Loc…
Arthrex, Inc.2005—

Also cleared against K031438: 8 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 15 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 7 of the 21 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K031438.

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. 2015, 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 Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

Indications for use as stated in the FDA summary.

Also cleared against K031438

8 other devices cite the same predicate.

  • K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
  • K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
  • K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
  • K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
  • K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015

More from Vilex IN Tennessee, Inc.

7 FDA decisions under this applicant name. See the company

  • K191289Bone Screw Line AdditionVilex IN Tennessee, Inc. · 2019
  • K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. · 2019
  • K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
  • K151881X-Fix Line AdditionsVilex IN Tennessee, Inc. · 20162 recalls
  • K150211EzFuze Implant SystemVilex IN Tennessee, 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/K151456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151456: Small Bone Nail Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151456

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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