510(k) · Cleared
Recalled · 2005S2 Femoral 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 Apr 25, 2002 after a 27-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 25, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK021026 S2 Femoral NailHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 2 of its ownK022632 Sign IM NailSurgical Implant Generation Network (Sign) · 2002
- Descendant · 2 generations on · 0 of its ownK163589 SIGN IM NailSign Fracture Care International · 2017
- Descendant · 2 generations on · 0 of its ownK152757 SIGN Hip Construct (SHC)Sign Fracture Care International · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021026 | S2 Femoral Nail | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K022632 | Sign IM Nail | Surgical Implant Generation Network (Sign) | 2002 | — |
| +2 | K163589 | SIGN IM Nail | Sign Fracture Care International | 2017 | — |
| +2 | K152757 | SIGN Hip Construct (SHC) | Sign Fracture Care International | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | — | T2™ Femoral Nail System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022632 | Sign IM Nail | 2002 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2005 | Not classified | Z-0166-06 | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a… |
| Oct 4, 2005 | Not classified | Z-0167-06 | Other | Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022632 (Surgical Implant Generation Network (Sign), 2002) has gone furthest, with 2 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021026 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021026: S2 Femoral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021026
Report an extraction error
Are you the manufacturer?
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