510(k) · Cleared
ClearedSynthes Adolescent Lateral Entry Femoral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 2, 2007 after a 36-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- May 2, 2007
- Review
- 36 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK070843 Synthes Adolescent Lateral Entry Femoral Nail SystemSynthes (Usa) · 2007
- Descendant · cites it directly · 7 of its ownK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111232Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · cites it directly7descendants
- K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · 2 generations on6descendants
- K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · cites it directly6descendants
- K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · 2 generations on4descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070843 | Synthes Adolescent Lateral Entry Femoral Nail System | Synthes (Usa) | 2007 | — |
| +1 | K111232 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2012 | 1 |
| +2 | K160545 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2016 | — |
| +1 | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | 27 |
| +2 | K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. | 2018 | 3 |
| +3 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | — | Smith & Nephew's Adolescent Nail Named without a submission number | |
| * | — | Biomet's Pediatric Locking Nail System Named without a submission number |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K111232 (Pega Medical, Inc., 2012) has gone furthest, with 7 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. 2007, 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?
Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070843 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070843: Synthes Adolescent Lateral Entry Femoral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070843
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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