510(k) · Cleared
ClearedPediatric Nailing Platform Femur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 20, 2022 as substantially equivalent to K172583 (Orthopediatrics, Inc., 2018) after a 134-day review. Its family tree reaches back 4 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 20, 2022
- Review
- 134 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K982953 (1998). 12 ancestors in all, the oldest K981529 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 3 generations backK993956 Titanium Pediatric Femoral NailBiomet, Inc. · 1999 · Recalled
- 2 generations backK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
- 1 generation backK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
- This deviceK220679 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022
- Descendant · cites it directly · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
- Descendant · cites it directly · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −3 | K993956 | Titanium Pediatric Femoral Nail | Biomet, Inc. | 1999 | 11 |
| −2 | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | 27 |
| −1 | K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. | 2018 | 3 |
| 0 (this device) | K220679 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2022 | — |
| +1 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +1 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K172583 | OrthoPediatrics PediNail Intramedullary PlatformSummary page 4…Orthopedic III. Predicate Device Substantial equivalence is claimed to the following predicate devices: Predicate Device: PediNail Intramedullary Platform, K172583, OrthoPediatrics Corp. Note: PediNail Intramedullary Platform (K172583) has been marketed as Pediatric Nailing Platform | Femur… | 2018 |
| † | K083726 | Pedinail Intramedullary Nailing System | 2009 |
What descends from it? (2)
2 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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 8 of the 12 ancestors have a recall of any class.
- Of its descendants, K250623 (OrthoPediatrics Corp., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K172583.
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. 2022, 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?
Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely…
Read the full statement (112 words)
Pediatric Nailing Platform | Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics Pediatric Nailing Platform | Femur is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220679: Pediatric Nailing Platform Femur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220679
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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