510(k) · Cleared
ClearedOrthopediatrics Pediplates 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 Jul 22, 2008 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) and 3 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1999. 65 later devices descend from it.
- Decided
- Jul 22, 2008
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K993106 (1999). 6 ancestors in all. 65 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
- 1 generation backK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
- This deviceK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
- Descendant · cites it directly · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- Descendant · 2 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- Descendant · cites it directly · 15 of its ownK090666 PediplatesOrthoPediatrics Corp. · 2009
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 13 of its ownK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · cites it directly60descendants
- K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 2 generations on28descendants
- K090666PediplatesOrthoPediatrics Corp. · 2009 · cites it directly15descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | Smith & Nephew, Inc. | 1999 | — |
| −1 | K073344 | Orthopediatrics Plating System | Orthopediatrics, LLC | 2008 | — |
| 0 (this device) | K081407 | Orthopediatrics Pediplates System | OrthoPediatrics Corp. | 2008 | — |
| +1 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| +2 | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| +1 | K090666 | Pediplates | OrthoPediatrics Corp. | 2009 | — |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K100240 | Orthopediatrics Pediloc Tibia Plate System | OrthoPediatrics Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K031493 | Growth Guidance PlateSummary page 1…ss IIper 21 CFR §888.3030 DEVICE PRODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: : Guided Growth Plate (K031493), Marketed by Orthofix - TC-100 Plating and Screw System (K993106), Smith & Nephew - PediPlate TM Plating System (K073344), O… | 2003 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…ODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: : Guided Growth Plate (K031493), Marketed by Orthofix - TC-100 Plating and Screw System (K993106), Smith & Nephew - PediPlate TM Plating System (K073344), OrthoPediatrics - Distal Tibia T-Plates (K080522), Synthes DEVICE… | 1999 |
| * | K073344 | Orthopediatrics Plating SystemSummary page 1…QUIVALENT DEVICES: : Guided Growth Plate (K031493), Marketed by Orthofix - TC-100 Plating and Screw System (K993106), Smith & Nephew - PediPlate TM Plating System (K073344), OrthoPediatrics - Distal Tibia T-Plates (K080522), Synthes DEVICE DESCRIPTION: The two and four-hole plates feature a conto… | 2008 |
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T Plates Cleared while this submission was under review Summary page 1…Marketed by Orthofix - TC-100 Plating and Screw System (K993106), Smith & Nephew - PediPlate TM Plating System (K073344), OrthoPediatrics - Distal Tibia T-Plates (K080522), Synthes DEVICE DESCRIPTION: The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. T… | 2008 |
What descends from it? (65)
See all 653 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 9 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K083286 (OrthoPediatrics Corp., 2009) has gone furthest, with 60 descendants of its own.
- 7 other devices also cite its predicate K031493.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The OrthoPediatrics PediPlate system is used for adult and pediatric patients as indicated for pelvic, small and long bone fractures. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerous, ulna, middle hand and middle foot bones, treatment of the calcaneal; hip arthodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is…
Read the full statement (132 words)
The OrthoPediatrics PediPlate system is used for adult and pediatric patients as indicated for pelvic, small and long bone fractures. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerous, ulna, middle hand and middle foot bones, treatment of the calcaneal; hip arthodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.
Specific pediatric conditions/diseases for which the devices will be indicated include:
• Valgus, varus, or flexion, extension deformities of the knee (femur and/or tibia)
• Valgus, varus, or plantar flexion deformities of the ankle
• Valgus or varus deformities of the elbow (humerus)
• Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081407: Orthopediatrics Pediplates System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081407
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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