510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Synthes Hindfoot Arthrodesis Nail System

K051678510(k) TraditionalCleared Sep 21, 200590-day reviewClass II21 CFR 888.3020Recalls 1

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

Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 21, 2005 after a 90-day review. The FDA summary names its predicate without a number. 16 later devices descend from it. It has been recalled once.

Decided
Sep 21, 2005
Review
90 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
0

16 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2026: 2 descendants cleared2019: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK051678 Synthes Hindfoot Arthrodesis Nail SystemSynthes (Usa) · 2005
  2. Descendant · cites it directly · 11 of its ownK112982 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012
  3. Descendant · 2 generations on · 9 of its ownK130147 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
  4. Descendant · 3 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  5. Descendant · 4 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  6. Descendant · 4 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22017: 12018: 12019: 22020: 32021: 12023: 12024: 12025: 12026: 2
2012high 3 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 16 · See all
  • K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012 · cites it directly11descendants
  • K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013 · 2 generations on9descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 4 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051678Synthes Hindfoot Arthrodesis Nail SystemSynthes (Usa)2005—
+1K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc.2012—
+2K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.2013—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201710
201810
201920
202030
202110
202310
202410
202510
202620
FIG. 1 — Lineage of K051678, 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 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? (2)

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
*—Biomet Inc. - Titanium Ankle Arthrodesis Nail
Named without a submission number
—
*—Synthes - 6.0 mm Locking Screws (accessory in Titanium Distal Femoral Nail System)
Named without a submission number
—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc.201211
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K130051611 Ankle Fusion NailTornier S.A.S.20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 24, 2024Class IIZ-1234-2024Process controlProducts not sterilized, sterility cannot be confirmed

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K112982 (Small Bone Innovations, Inc., 2012) has gone furthest, with 11 descendants of its own.

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.

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 Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K051678 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051678: Synthes Hindfoot Arthrodesis Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051678

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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