510(k) · Cleared
ClearedS2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 15, 2012 as substantially equivalent to K032579 (Howmedica Osteonics Corp., 2003) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Feb 15, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K013468 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- 2 generations backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- 1 generation backK102992 T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130…Howmedica Osteonics Corp. · 2010
- This deviceK113409 S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2…Howmedica Osteonics Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| −2 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| −1 | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees | Howmedica Osteonics Corp. | 2010 | — |
| 0 (this device) | K113409 | S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial… | Howmedica Osteonics Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032579 | S2 Nail SystemSummary page 1…Mahwah, NJ 07430 Phone: (201) 831 -5992; Fax (201)83 1-4992 Legally Marketed Devices to Which K032579 -5S2 Nail System Substantial Equivalence Is Claimned: K 102992 - T2® Recon Nail System Date Prepared:… | 2003 |
| * | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesSummary page 1…Phone: (201) 831 -5992; Fax (201)83 1-4992 Legally Marketed Devices to Which K032579 -5S2 Nail System Substantial Equivalence Is Claimned: K 102992 - T2® Recon Nail System Date Prepared: Novem ber 17, 2011 Description This Traditional 5 10(k) sub… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
S2 Tibial Nail The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: * Open and closed tibial fractures *…
Read the full statement (161 words)
S2 Tibial Nail
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
* Open and closed tibial fractures
* Pseudoarthrosis and correction osteotomy
* Pathologic fractures, impending pathologic fractures, and tumor resections
* Nonunion and malunion
S2 Femoral Nail
The S2 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 a hip joint
* Nonunions and malunions,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113409: S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113409
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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