510(k) Report

510(k) · Cleared

Cleared

T2 Femoral Nail

K081152510(k) SpecialCleared Jun 10, 200848-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 Jun 10, 2008 after a 48-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.

Decided
Jun 10, 2008
Review
48 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

27 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2020: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2023: 3 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 4 descendants cleared2022: 4 descendants cleared2018: 1 descendant cleared2025: 3 descendants cleared20052010201520202025
  1. This deviceK081152 T2 Femoral NailHowmedica Osteonics Corp. · 2008
  2. Descendant · cites it directly · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
  3. Descendant · cites it directly · 10 of its ownK112059 T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011
  4. Descendant · 2 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
  5. Descendant · 3 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
  6. Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 12013: 12014: 22015: 22017: 12018: 12020: 12021: 12022: 42023: 32024: 12025: 32026: 4
2009high 4 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 27 · See all
  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · cites it directly11descendants
  • K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker · 2011 · cites it directly10descendants
  • K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 2 generations on7descendants
  • K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 3 generations on3descendants
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081152T2 Femoral NailHowmedica Osteonics Corp.2008—
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail…Stryker GmbH2020—
+1K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker2011—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker GmbH2021—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH20221
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201110
201310
201420
201520
201710
201810
202010
202110
202240
202330
202410
202530
202640
FIG. 1 — Lineage of K081152, 2008–2026Source: 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
*—T2 Femoral Nail System
Named without a submission number
—

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011
K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker201110
K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp.20101
K152295Talon DistalFix Antegrade/Retrograde Femoral NailOrthopedic Designs North America, Inc.20150
K141347Emerge Medical IM Nail SystemEmerge Medical20140
K092771Dyna Locking IM NailU&I Corp.20090

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, K200880 (Stryker GmbH, 2020) has gone furthest, with 11 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. 2008, 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 T2TM Femoral Nail is 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

* Supracondylar fractures, including those with intra-articular extension

* Ipsilateral femur fractures

* Fractures proximal to a total knee arthroplasty

* Fractures distal to hip joint

* Nonunions and malunions

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/K081152 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081152: T2 Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081152

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 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026