510(k) · Cleared
Recalled · Class II · 2019OrthoPediatrics PediNail Intramedullary Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopediatrics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 10, 2018 as substantially equivalent to K083726 (OrthoPediatrics Corp., 2009) after a 255-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- May 10, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982953 (1998). 11 ancestors in all, the oldest K981529 (1998). 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 2 generations backK993956 Titanium Pediatric Femoral NailBiomet, Inc. · 1999 · Recalled
- 1 generation backK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
- This deviceK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK220679 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
- Descendant · cites it directly · 0 of its ownK190321 Pediatric Nailing PlatformFemurOrthoPediatrics Corp. · 2019
Most influential descendants
Showing 4 of 4 · See all- K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022 · cites it directly2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · cites it directly1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · cites it directly0descendants
- K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −2 | K993956 | Titanium Pediatric Femoral Nail | Biomet, Inc. | 1999 | 11 |
| −1 | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | 27 |
| 0 (this device) | K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. | 2018 | — |
| +1 | 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 | — |
| +1 | K190321 | Pediatric Nailing PlatformFemur | OrthoPediatrics Corp. | 2019 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K083726 | Pedinail Intramedullary Nailing SystemSummary page 4…: HSB Common Name: Rod, Fixation, Intramedullary and Accessories Legally marketed devices to which substantial equivalence is claimed: • K083726 – OrthoPediatrics PediNail Intramedullary Nailing System Device Description The OrthoPediatrics PediNail Intramedullary Nailing… | 2009 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2019 | Class II | Z-0125-2020 | Device Design | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures |
| Aug 19, 2019 | Class II | Z-0218-2020 | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. |
| Aug 19, 2019 | Class II | Z-0219-2020 | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K220679 (OrthoPediatrics Corp., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083726.
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. 2018, 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?
The OrthoPediatrics PediNail Intramedullary Platform 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 includes simple long bone…
Read the full statement (110 words)
The OrthoPediatrics PediNail Intramedullary Platform 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 includes 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 PediNail Intramedullary Platform is for single use only.
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/K172583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172583: OrthoPediatrics PediNail Intramedullary Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172583
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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