510(k) Report

510(k) · Cleared

Cleared

Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )

K112982510(k) TraditionalCleared Apr 2, 2012179-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

Small Bone Innovations, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Apr 2, 2012 as substantially equivalent to K051590 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 179-day review. Its family tree reaches back 1 generation to 2005. 11 later devices descend from it.

Decided
Apr 2, 2012
Review
179 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K051590 (2005). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2013: 1 descendant cleared2017: 1 descendant cleared2019: 2 descendants cleared2023: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK051590 · T2 Ankle Arthrodesis Nail · Howmedica Osteonics Corp. · 2005 · recalled20052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants K051590 · T2 Ankle Arthrodesis Nail · Howmedica Osteonics Corp. · 2005 · recalled0+5
  1. Root · 1 generation backK051590 T2 Ankle Arthrodesis NailHowmedica Osteonics Corp. · 2005 · Recalled
  2. This deviceK112982 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012
  3. Descendant · cites it directly · 9 of its ownK130147 Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
  4. Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  5. Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  6. Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
  7. Descendant · 4 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2013: 12017: 12019: 22020: 22021: 12023: 12024: 12025: 12026: 1
2013high 2 (2019) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013 · cites it directly9descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 3 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on6descendants
  • K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051590T2 Ankle Arthrodesis NailHowmedica Osteonics Corp.20058
0 (this device)K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc.2012—
+1K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.2013—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201710
201920
202020
202110
202310
202410
202510
202610
FIG. 1 — Lineage of K112982, 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
*K051590T2 Ankle Arthrodesis NailHowmedica Osteonics Corp.20058
*K051678Synthes Hindfoot Arthrodesis Nail SystemSynthes (Usa)20051

Also cleared against K051590: 9 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.20139
K163589SIGN IM NailSign Fracture Care International20170

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?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K130147 (Small Bone Innovations, Inc., 2013) has gone furthest, with 9 descendants of its own.
  • 9 other devices also cite its predicate K051590.

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. 2012, 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 SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for

tibiotalocalcaneal arthrodesis of the ankle following:

- Post traumatic and degenerative arthritis involving both ankle and subtalar joints,

- Rheumatoid arthritis,

- Osteoarthritis,

- Pseudoarthrosis,

- Severe foot/ankle deformity, or

- Instability and skeletal defects after tumor resection.

These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus,

failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when

used concomitantly with tibiotalocalcaneal pathology.

Indications for use as stated in the FDA summary.

Also cleared against K051590

9 other devices cite the same predicate.

  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2…Stryker GmbH · 2020
  • K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas · 2018
  • K163589SIGN IM NailSign Fracture Care International · 2017
  • K130051611 Ankle Fusion NailTornier S.A.S. · 2013
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K120419Dyna Locking Ankle NailU&I Corp. · 2012

More from Small Bone Innovations, Inc.

20 FDA decisions under this applicant name. See the company

  • K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
  • K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 20109 recalls
  • K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc. · 2010
  • K093550Mini Rail External Fixator SystemSmall Bone Innovations, Inc. · 2010
  • K073635Sbi SR MTP Toe ImplantSmall Bone Innovations, Inc. · 2008

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/K112982 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112982

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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