510(k) · Cleared
Recalled · Class III · 2016Pedinail Intramedullary Nailing System
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 Mar 11, 2009 as substantially equivalent to K040929 (Smith & Nephew, Inc., 2004) and 5 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1998. 6 later devices descend from it. It has been recalled 27 times.
- Decided
- Mar 11, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 27
- Predicates
- 6
Its longest line of descent runs back 2 generations to K982953 (1998). 10 ancestors in all, the oldest K981529 (1998). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 1 generation backK993956 Titanium Pediatric Femoral NailBiomet, Inc. · 1999 · Recalled
- This deviceK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009
- Descendant · cites it directly · 4 of its ownK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK220679 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022
- Descendant · 2 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK190321 Pediatric Nailing PlatformFemurOrthoPediatrics Corp. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · cites it directly4descendants
- K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2022 · 2 generations on2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 2 generations on0descendants
- K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982953 | Titanium Intramedullary Nails-Various Styles | Biomet, Inc. | 1998 | 4 |
| −1 | K993956 | Titanium Pediatric Femoral Nail | Biomet, Inc. | 1999 | 11 |
| 0 (this device) | K083726 | Pedinail Intramedullary Nailing System | OrthoPediatrics Corp. | 2009 | — |
| +1 | K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. | 2018 | 3 |
| +2 | K220679 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2022 | — |
| +2 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +2 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K040929 | Trigen Adolescent TanSummary page 1…xation rod and accessories: Class iI per 21 CFR §888.3020 DEVICE PRODUCT CODE(S): HSB SUBSTANTIALLY EQUIVALENT DEVICES: K040929, Tri-Gen Adolescent TAN, Smith & Nephew K070843, Adolescent Lateral Entry Nail, Synthes K983942, Intramedullary Nail System… | 2004 |
| * | K070843 | Synthes Adolescent Lateral Entry Femoral Nail SystemSummary page 1…sories: Class iI per 21 CFR §888.3020 DEVICE PRODUCT CODE(S): HSB SUBSTANTIALLY EQUIVALENT DEVICES: K040929, Tri-Gen Adolescent TAN, Smith & Nephew K070843, Adolescent Lateral Entry Nail, Synthes K983942, Intramedullary Nail System (stainless steel), Smith & Nephew K993956, Tita… | 2007 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 1…CT CODE(S): HSB SUBSTANTIALLY EQUIVALENT DEVICES: K040929, Tri-Gen Adolescent TAN, Smith & Nephew K070843, Adolescent Lateral Entry Nail, Synthes K983942, Intramedullary Nail System (stainless steel), Smith & Nephew K993956, Titanium Pediatric Femoral Nail, Biomet K072161, Fem… | 1998 |
| * | K993956 | Titanium Pediatric Femoral NailSummary page 1…29, Tri-Gen Adolescent TAN, Smith & Nephew K070843, Adolescent Lateral Entry Nail, Synthes K983942, Intramedullary Nail System (stainless steel), Smith & Nephew K993956, Titanium Pediatric Femoral Nail, Biomet K072161, Femoral Locking Nail System, Biomet K040336, Lateral Entry Femoral Nail S… | 1999 |
| * | K072161 | Biomet Femoral Locking Nail SystemSummary page 1…3, Adolescent Lateral Entry Nail, Synthes K983942, Intramedullary Nail System (stainless steel), Smith & Nephew K993956, Titanium Pediatric Femoral Nail, Biomet K072161, Femoral Locking Nail System, Biomet K040336, Lateral Entry Femoral Nail System, Synthes DEVICE DESCRIPTION: OrthoPediatrics… | 2007 |
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 1…3942, Intramedullary Nail System (stainless steel), Smith & Nephew K993956, Titanium Pediatric Femoral Nail, Biomet K072161, Femoral Locking Nail System, Biomet K040336, Lateral Entry Femoral Nail System, Synthes DEVICE DESCRIPTION: OrthoPediatrics intramedullary rods (nails) are generally rod-s… | 2004 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2016 | Class III | Z-0879-2017 | Labeling mix-ups | Labeled as a 48mm Cortical Screw but measuring at 50mm |
| Jul 21, 2009 | Not classified | Z-0339-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0342-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0345-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0346-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0348-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0350-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0351-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0353-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-034-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0347-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0352-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0357-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0361-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0362-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0363-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0341-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0344-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0349-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0354-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0355-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0356-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0358-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0359-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0343-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0360-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
| Jul 21, 2009 | Not classified | Z-0364-2010 | Device Design | The potential exists for the nails to fracture during insertion of the nail. |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K172583 (Orthopediatrics, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K040929.
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. 2009, 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 PediNailTM system 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 malunions; 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 (107 words)
The OrthoPediatrics PediNailTM system 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 malunions; 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' PediNailTM is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083726: Pedinail Intramedullary Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083726
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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