510(k) Report

510(k) · Cleared

Cleared

Ace Bio Win Tibial Nailing System

K013430510(k) TraditionalCleared Dec 17, 200162-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

DePuy Orthopaedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 17, 2001 as substantially equivalent to K972183 (Ace Medical Co., 1997) and 2 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1992. 48 later devices descend from it.

Decided
Dec 17, 2001
Review
62 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K914453 (1992). 3 ancestors in all. 48 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor2003: 1 descendant cleared2018: 3 descendants cleared2008: 2 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2007: 1 descendant cleared2023: 4 descendants cleared2013: 3 descendants cleared2014: 2 descendants cleared2017: 2 descendants cleared2024: 2 descendants cleared2009: 1 descendant cleared2026: 7 descendants cleared2025: 8 descendants cleared2019: 3 descendants cleared2020: 3 descendants cleared2021: 1 descendant cleared2022: 3 descendants clearedK914453 · Universal Tibial Nail and Unreamed Tibial Nail · Synthes (Usa) · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 13 descendants4 generations forward: 8 descendants5 generations forward: 6 descendants6 generations forward: 10 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K914453 · Universal Tibial Nail and Unreamed Tibial Nail · Synthes (Usa) · 19920+5
  1. Root · 1 generation backK914453 Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa) · 1992
  2. This deviceK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001
  3. Descendant · cites it directly · 47 of its ownK032097 Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003
  4. Descendant · 2 generations on · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
  6. Descendant · 4 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
  7. Descendant · 2 generations on · 11 of its ownK080706 Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2003: 12007: 12008: 22009: 12012: 12013: 32014: 22015: 12017: 22018: 32019: 32020: 32021: 12022: 32023: 42024: 22025: 82026: 7
2003high 8 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 48 · See all
  • K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003 · cites it directly47descendants
  • K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · 2 generations on35descendants
  • K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 3 generations on16descendants
  • K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 4 generations on15descendants
  • K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914453Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa)1992—
0 (this device)K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc.2001—
+1K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc.2003—
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.200815
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker Trauma GmbH2018—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System…Stryker Trauma GmbH2019—
+2K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200710
200820
200910
201210
201330
201420
201510
201720
201830
201930
202030
202110
202230
202340
202420
202580
202670
FIG. 1 — Lineage of K013430, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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
*K972183Depuy Ace a.I.M. Titanium Tibial Nail
Summary page 1
…under Section 514 of the Federal Food, Drug, and Cosmetic Act for intramedullary nails or bone fixation fasteners. Substantially Equivalent Device: ACE AIM Tibial Nail K972183 Synthes AO Nail K914453 Biomet LactoSorb® 5.0mm washer K001581 Device Descriptions: The BioWin Tibial Nailing System consists of…
Ace Medical Co.19972
*K914453Universal Tibial Nail and Unreamed Tibial Nail
Summary page 1
…e Federal Food, Drug, and Cosmetic Act for intramedullary nails or bone fixation fasteners. Substantially Equivalent Device: ACE AIM Tibial Nail K972183 Synthes AO Nail K914453 Biomet LactoSorb® 5.0mm washer K001581 Device Descriptions: The BioWin Tibial Nailing System consists of an intramedullary nail,…
Synthes (Usa)1992—
*K001581Lactosorb 5.0 MM Washer
Summary page 1
…for intramedullary nails or bone fixation fasteners. Substantially Equivalent Device: ACE AIM Tibial Nail K972183 Synthes AO Nail K914453 Biomet LactoSorb® 5.0mm washer K001581 Device Descriptions: The BioWin Tibial Nailing System consists of an intramedullary nail, cortical screws, end cap, and an optio…
Biomet, Inc.2001—

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K032097Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc.200347

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K032097 (DePuy Orthopaedics, Inc., 2003) has gone furthest, with 47 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 ACE BioWin Tibial Nailing System is indicated in reamed and unreamed

applications for internal fixation of tibial fractures including transverse fractures, oblique

fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone

loss, bone transport, open fractures, corrective osteotomies, pathologic fractures,

pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and

epiphyseal fractures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K013430 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013430: Ace Bio Win Tibial Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013430

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026