510(k) · Cleared
Recalled · Class II · 2020S2 Nail System
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 Aug 29, 2003 after an 8-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 29, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032579 S2 Nail SystemHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK113409 S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2…Howmedica Osteonics Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113409S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression NailHowmedica Osteonics Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032579 | S2 Nail System | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K113409 | S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial… | Howmedica Osteonics Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | S2 Nail System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113409 | S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2020 | Class II | Z-2373-2020 | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113409 (Howmedica Osteonics Corp., 2012) has gone furthest, with 0 descendants of its own.
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.
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, malunion 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…
Read the full statement (149 words)
S2 Tibial Nail
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion 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/K032579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032579: S2 Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032579
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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