510(k) Report

510(k) · Cleared

Cleared

Modification to T2 Proximal Humeral Nail

K043404510(k) SpecialCleared Dec 27, 200417-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

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

Cleared on Dec 27, 2004 after a 17-day review. The FDA summary names no predicate by number. 32 later devices descend from it.

Decided
Dec 27, 2004
Review
17 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared2014: 1 descendant cleared2005: 1 descendant cleared2011: 3 descendants cleared2015: 2 descendants cleared2013: 3 descendants cleared2016: 3 descendants cleared2012: 1 descendant cleared2017: 3 descendants cleared2020: 3 descendants cleared2018: 1 descendant cleared2019: 3 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK043404 Modification to T2 Proximal Humeral NailHowmedica Osteonics Corp. · 2004
  2. Descendant · cites it directly · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  3. Descendant · 2 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
  4. Descendant · 2 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
  5. Descendant · 2 generations on · 15 of its ownK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  6. Descendant · 3 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005: 12010: 12011: 32012: 12013: 32014: 12015: 22016: 32017: 32018: 12019: 32020: 32021: 12022: 12023: 12024: 12025: 12026: 2
2005high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 32 · See all
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · cites it directly29descendants
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 2 generations on16descendants
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 2 generations on15descendants
  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011 · 2 generations on15descendants
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043404Modification to T2 Proximal Humeral NailHowmedica Osteonics Corp.2004—
+1K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.20111
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20111
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.2011—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201010
201130
201210
201330
201410
201520
201630
201730
201810
201930
202030
202110
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K043404, 2004–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029
K141347Emerge Medical IM Nail SystemEmerge Medical20140
K052294Shoulder Nail PlateHand Innovations, LLC20050

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, K100497 (N.M.B. Medical Applications, Ltd., 2010) has gone furthest, with 29 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 T2 Proximal Humeral Nail is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Indications for use as stated in the FDA summary.

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/K043404 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043404: Modification to T2 Proximal Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043404

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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