510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

T2 Arthrodesis Nail System

K020384510(k) TraditionalCleared May 6, 200290-day reviewClass II21 CFR 888.3020Recalls 1

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 May 6, 2002 after a 90-day review. The FDA summary names no predicate by number. 16 later devices descend from it. It has been recalled once.

Decided
May 6, 2002
Review
90 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
0

16 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2012: 2 descendants cleared2020: 1 descendant cleared2025: 4 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 3 descendants cleared2023: 1 descendant cleared2022: 2 descendants cleared200020052010201520202025
  1. This deviceK020384 T2 Arthrodesis Nail SystemHowmedica Osteonics Corp. · 2002
  2. Descendant · cites it directly · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
  3. Descendant · 2 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
  4. Descendant · 3 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
  5. Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
  6. Descendant · 4 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2004: 12012: 22020: 12021: 12022: 22023: 12024: 12025: 42026: 3
2004high 4 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 16 · See all
  • K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · cites it directly11descendants
  • 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
  • K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020384T2 Arthrodesis Nail SystemHowmedica Osteonics Corp.2002—
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail…Stryker GmbH2020—
+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—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201220
202010
202110
202220
202310
202410
202540
202630
FIG. 1 — Lineage of K020384, 2002–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (16)

See all 16

4 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
K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited20121
K102577Force Medical IM Nail SystemForce Medical, Inc.20120
K042409Modular Arthrodesis NailBiomet, Inc.20040

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 26, 2012Class IIZ-2016-2012PackagingStryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.

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.

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 Arthrodesis Nail is indicated for long bone internal fixation, which may include the following:

The subject device is indicated for long bone 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

• Failed external fixation, nonunions and malunions

• Periarticular fractures where repair is not possible

• Aseptic failed total knee arthroplasty

• Knee arthrodesis

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K020384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020384: T2 Arthrodesis 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/K020384

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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