510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

T2 Humeral Nail System

K011529510(k) SpecialCleared Jun 12, 200126-day reviewClass II21 CFR 888.3020Recalls 3

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

Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jun 12, 2001 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled 3 times.

Decided
Jun 12, 2001
Review
26 days
Class
Class II
Product code
HSB
Recalls
3
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2018: 2 descendants cleared2012: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK011529 T2 Humeral Nail SystemHowmedica Osteonics Corp. · 2001
  2. Descendant · cites it directly · 10 of its ownK033878 Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004
  3. Descendant · 2 generations on · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
  4. Descendant · 3 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
  5. Descendant · 4 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2004: 12012: 12018: 22020: 12023: 12024: 12025: 32026: 1
2004high 3 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all
  • K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004 · cites it directly10descendants
  • K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · 2 generations on6descendants
  • K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 3 generations on4descendants
  • K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 4 generations on2descendants
  • K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011529T2 Humeral Nail SystemHowmedica Osteonics Corp.2001—
+1K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace2004—
+2K181827Affixus Natural Nail System Humeral NailZimmer GmbH2018—
+3K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®…Zimmer Switzerland Manufacturing GmbH2023—
+4K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.202417
+3K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201210
201820
202010
202310
202410
202530
202610
FIG. 1 — Lineage of K011529, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace200410

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

Recalls of this device

DateClassRecallRoot causeReason
May 7, 2020Class IIZ-2377-2020Process controlSeal integrity of the blister pack may be compromised and sterility cannot be assured
May 7, 2020Class IIZ-2378-2020Process controlSeal integrity of the blister pack may be compromised and sterility cannot be assured
May 7, 2020Class IIZ-2376-2020Process controlSeal integrity of the blister pack may be compromised and sterility cannot be assured

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033878 (Depuy Ace, 2004) has gone furthest, with 10 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—

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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/K011529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011529: T2 Humeral 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/K011529

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026