510(k) Report

510(k) · Cleared

Cleared

Modification of Depuy Ace Timax Medial Pilon Plate

K990120510(k) SpecialCleared Feb 1, 199919-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 Ace Medical Co. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 1, 1999 after a 19-day review. The FDA summary names its predicate without a number. 221 later devices descend from it.

Decided
Feb 1, 1999
Review
19 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 3 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2010: 2 descendants cleared2005: 1 descendant cleared2025: 20 descendants cleared2017: 10 descendants cleared2014: 11 descendants cleared2011: 3 descendants cleared2018: 5 descendants cleared2021: 17 descendants cleared2020: 16 descendants cleared2024: 27 descendants cleared2016: 8 descendants cleared2023: 27 descendants cleared2019: 17 descendants cleared2015: 9 descendants cleared2008: 1 descendant cleared2013: 3 descendants cleared2022: 13 descendants cleared2026: 22 descendants cleared1995200020052010201520202025
  1. This deviceK990120 Modification of Depuy Ace Timax Medial Pilon PlateDepuy Ace Medical Co. · 1999
  2. Descendant · cites it directly · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
  4. Descendant · 2 generations on · 65 of its ownK100652 Acl TightropeArthrex, Inc. · 2010
  5. Descendant · cites it directly · 58 of its ownK072832 Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010

Showing 5 of 221 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12007: 22008: 12009: 22010: 22011: 32012: 32013: 32014: 112015: 92016: 82017: 102018: 52019: 172020: 162021: 172022: 132023: 272024: 272025: 202026: 22
2003high 27 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 221 · See all
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · cites it directly161descendants
  • K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 2 generations on143descendants
  • K100652Acl TightropeArthrex, Inc. · 2010 · 2 generations on65descendants
  • K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly58descendants
  • K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · 2 generations on55descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990120Modification of Depuy Ace Timax Medial Pilon PlateDepuy Ace Medical Co.1999—
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006—
+2K100652Acl TightropeArthrex, Inc.2010—
+1K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc.20072
+2K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200720
200810
200920
201020
201130
201230
201330
2014110
201590
201680
2017100
201850
2019170
2020160
2021170
2022130
2023270
2024270
2025200
2026220
FIG. 1 — Lineage of K990120, 1999–2026Source: 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? (1)

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
*—DePuy ACE TiMAX™ Pilon Plate
Named without a submission number
—

What descends from it? (221)

See all 221

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

NumberDeviceApplicantDecidedDescendants
K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.2003161
K072832Anterolateral and Medial Locking Plating SystemDePuy Orthopaedics, Inc.200758
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121

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?

  • Of its descendants, K031666 (Arthrex, Inc., 2003) has gone furthest, with 161 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?

Pilon fractures - distal tibial intra-articular fractures

High medial malleolar fractures

Low boot top type rotational distal extra-articular shaft 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 Ace Medical Co.

10 FDA decisions under this applicant name. See the company

  • K990392Depuy Ace Spider PlateDepuy Ace Medical Co. · 1999
  • K984458Depuy Ace Spider PlateDepuy Ace Medical Co. · 1998
  • K983853Depuy Ace Timax Meta PlateDepuy Ace Medical Co. · 1998
  • K983265Depuy Ace Composite Locking NutDepuy Ace Medical Co. · 1998
  • K982347Depuy Ace Timax Pilon PlateDepuy Ace Medical Co. · 1998

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/K990120 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990120: Modification of Depuy Ace Timax Medial Pilon Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990120

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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