510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

T2 Greater Trochanter Nail

K101438510(k) SpecialCleared Jun 17, 201024-day reviewClass II21 CFR 888.3020Recalls 2

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 17, 2010 as substantially equivalent to K010801 (Howmedica Osteonics Corp., 2001) after a 24-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it. It has been recalled 2 times.

Decided
Jun 17, 2010
Review
24 days
Class
Class II
Product code
HSB
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K010801 (2001). 25 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2020: 3 descendants cleared2018: 3 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2026: 4 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2025: 5 descendants cleared2022: 3 descendants clearedK010801 · T2 Femoral Nail · Howmedica Osteonics Corp. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 5 descendants5 generations forward: 6 descendants K010801 · T2 Femoral Nail · Howmedica Osteonics Corp. · 2001 · recalled0+5
  1. Root · 1 generation backK010801 T2 Femoral NailHowmedica Osteonics Corp. · 2001 · Recalled
  2. This deviceK101438 T2 Greater Trochanter NailHowmedica Osteonics Corp. · 2010
  3. Descendant · cites it directly · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
  4. Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
  5. Descendant · 3 generations on · 15 of its ownK191271 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia…Stryker Trauma GmbH · 2019
  6. Descendant · cites it directly · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
  7. Descendant · 4 generations on · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2015: 12018: 32019: 12020: 32021: 12022: 32023: 22024: 22025: 52026: 4
2015high 5 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 25 · See all
  • K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · cites it directly17descendants
  • K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
  • K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH · 2019 · 3 generations on15descendants
  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · cites it directly11descendants
  • K200869Gamma3 SystemStryker Trauma GmbH · 2020 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010801T2 Femoral NailHowmedica Osteonics Corp.20012
0 (this device)K101438T2 Greater Trochanter NailHowmedica Osteonics Corp.2010—
+1K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…Stryker Trauma GmbH2018—
+2K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker Trauma GmbH2018—
+3K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System…Stryker Trauma GmbH2019—
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail…Stryker GmbH2020—
+4K200869Gamma3 SystemStryker Trauma GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201830
201910
202030
202110
202230
202320
202420
202550
202640
FIG. 1 — Lineage of K101438, 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), 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
*K010801T2 Femoral Nail
Summary page 1
…ither a retrograde or antegrade surgical approach. Description of Device Modification The predicate device is the T2 Femnoral Nail A/R which was cleared for sale under K010801 in April 2001. The intended use and indications are the same. The difference between T2 GTN and the predicate is that the nail en…
Howmedica Osteonics Corp.20012

Also cleared against K010801: 11 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817
K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011
K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152

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

Recalls of this device

DateClassRecallRoot causeReason
May 22, 2025Class IIZ-1940-2025Under Investigation by firmInvestigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
May 22, 2025Class IIZ-1939-2025Under Investigation by firmInvestigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K172774 (Stryker Trauma GmbH, 2018) has gone furthest, with 17 descendants of its own.
  • 11 other devices also cite its predicate K010801.

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. 2010, 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 subject and predicate devices are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:

Open and closed femoral fractures

Pseudoarthrosis and correction osteotomy

Pathologic fractures, impending pathologic fractures, and tumor resections

Ipsilateral femur fractures

Fractures proximal to a total knee arthoplasty

Nonunions and malunions

Indications for use as stated in the FDA summary.

Also cleared against K010801

11 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
  • K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden…Truemed Group, LLC · 2018
  • K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014
  • K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 20111 recall
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20111 recall

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/K101438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101438: T2 Greater Trochanter Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101438

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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