510(k) · Cleared
ClearedOrthopediatrics Pediloc Tibia Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · HRS Plate, Fixation, Bone
Cleared on May 17, 2010 as substantially equivalent to K080522 (Synthes (Usa), 2008) and 2 other predicates after a 110-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it.
- Decided
- May 17, 2010
- Review
- 110 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962616 (1996). 39 ancestors in all, the oldest K890939 (1989). 13 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- This deviceK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- Descendant · cites it directly · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · cites it directly · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK200246 JPS JuniOrtho Plating SystemOrthofix Srl · 2020
- Descendant · 2 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly7descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
- K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly2descendants
- K200246JPS JuniOrtho Plating SystemOrthofix Srl · 2020 · cites it directly1descendant
- K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| 0 (this device) | K100240 | Orthopediatrics Pediloc Tibia Plate System | OrthoPediatrics Corp. | 2010 | — |
| +1 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| +2 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +1 | K110959 | Orthopediatrics Blade Plate System | OrthoPediatrics Corp. | 2011 | 3 |
| +1 | K200246 | JPS JuniOrtho Plating System | Orthofix Srl | 2020 | — |
| +2 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | OrthoPediatrics Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T PlatesSummary page 1…on appliances and accessories: Class II per 21 CIFR §888.3030 PRODUCT CODE: HIRS, HWC SUBSTANTIALLY EQUIVALENT DEVICES: K080522, LCP Distal Tibia T-Plates, Synthes K083286, PediLoc Locking Plate System, OrthoPediatrics K090665, PediPlate System, Ortho… | 2008 |
| * | K083286 | Orthopediatrics Pediloc Locking Plate SystemSummary page 1…Class II per 21 CIFR §888.3030 PRODUCT CODE: HIRS, HWC SUBSTANTIALLY EQUIVALENT DEVICES: K080522, LCP Distal Tibia T-Plates, Synthes K083286, PediLoc Locking Plate System, OrthoPediatrics K090665, PediPlate System, OrthoPediatrics DEVICE DESCRIPTION: The OrthoPediatr… | 2009 |
| * | K090666 | Pediplates Our reading of the summary gave K090665, FDA’s number for Emboshield NAV6 Embolic Protection System-Small/Large… (Abbott Vascular-Vascular Solutions). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PediPlate System, OrthoPediatrics”. | 2009 |
What descends from it? (13)
See all 134 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 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 39 ancestors have a recall of any class.
- Of its descendants, K111086 (OrthoPediatrics Corp., 2011) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K080522.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
OrthoPediatrics PediLocTm Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100240: Orthopediatrics Pediloc Tibia Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100240
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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