510(k) · Cleared
ClearedPediplates
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 Apr 24, 2009 as substantially equivalent to K081407 (OrthoPediatrics Corp., 2008) and 7 other predicates after a 42-day review. Its family tree reaches back 3 generations to 1999. 15 later devices descend from it.
- Decided
- Apr 24, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K993106 (1999). 10 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
- 2 generations backK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
- 1 generation backK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
- This deviceK090666 PediplatesOrthoPediatrics Corp. · 2009
- Descendant · cites it directly · 13 of its ownK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- Descendant · 2 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK200246 JPS JuniOrtho Plating SystemOrthofix Srl · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010 · cites it directly13descendants
- K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on7descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 3 generations on2descendants
- K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011 · 2 generations on2descendants
- K200246JPS JuniOrtho Plating SystemOrthofix Srl · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | Smith & Nephew, Inc. | 1999 | — |
| −2 | K073344 | Orthopediatrics Plating System | Orthopediatrics, LLC | 2008 | — |
| −1 | K081407 | Orthopediatrics Pediplates System | OrthoPediatrics Corp. | 2008 | — |
| 0 (this device) | K090666 | Pediplates | OrthoPediatrics Corp. | 2009 | — |
| +1 | K100240 | Orthopediatrics Pediloc Tibia Plate System | OrthoPediatrics Corp. | 2010 | — |
| +2 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| +3 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +2 | K110959 | Orthopediatrics Blade Plate System | OrthoPediatrics Corp. | 2011 | 3 |
| +2 | K200246 | JPS JuniOrtho Plating System | Orthofix Srl | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K081407 | Orthopediatrics Pediplates SystemSummary page 1…cessories: Class il per 21 CFR §888.3030 DEVICE PRODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: -.. · K081407, PediPlate TM Plating System, OrthoPediatrics * K073344, PediPlate TM Plating System, OrthoPediatrics * K031493, Guided Grow… | 2008 |
| * | K073344 | Orthopediatrics Plating SystemSummary page 1…§888.3030 DEVICE PRODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: -.. · K081407, PediPlate TM Plating System, OrthoPediatrics * K073344, PediPlate TM Plating System, OrthoPediatrics * K031493, Guided Growth Plate, Marketed by Orthofix * K020221, IQL Stainless S… | 2008 |
| * | K031493 | Growth Guidance PlateSummary page 1…and HWC SUBSTANTIALLY EQUIVALENT DEVICES: -.. · K081407, PediPlate TM Plating System, OrthoPediatrics * K073344, PediPlate TM Plating System, OrthoPediatrics * K031493, Guided Growth Plate, Marketed by Orthofix * K020221, IQL Stainless Steel Plates, Biomet * K993106, TC-100 Plating and Screw… | 2003 |
| * | K020221 | Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql…Summary page 1…81407, PediPlate TM Plating System, OrthoPediatrics * K073344, PediPlate TM Plating System, OrthoPediatrics * K031493, Guided Growth Plate, Marketed by Orthofix * K020221, IQL Stainless Steel Plates, Biomet * K993106, TC-100 Plating and Screw System, Smith & Nephew * K000684, Small Fragment DCL… | 2002 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 1…cs * K073344, PediPlate TM Plating System, OrthoPediatrics * K031493, Guided Growth Plate, Marketed by Orthofix * K020221, IQL Stainless Steel Plates, Biomet * K993106, TC-100 Plating and Screw System, Smith & Nephew * K000684, Small Fragment DCL System, Synthes * K013248, LCP Distal Tibial P… | 1999 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…* K031493, Guided Growth Plate, Marketed by Orthofix * K020221, IQL Stainless Steel Plates, Biomet * K993106, TC-100 Plating and Screw System, Smith & Nephew * K000684, Small Fragment DCL System, Synthes * K013248, LCP Distal Tibial Plates, Synthes · K080522, LCP Distal Tibial T-plates, Synth… | 2000 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 1…rthofix * K020221, IQL Stainless Steel Plates, Biomet * K993106, TC-100 Plating and Screw System, Smith & Nephew * K000684, Small Fragment DCL System, Synthes * K013248, LCP Distal Tibial Plates, Synthes · K080522, LCP Distal Tibial T-plates, Synthes DEVICE DESCRIPTION: The two and four-hole p… | 2001 |
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T PlatesSummary page 1…, Biomet * K993106, TC-100 Plating and Screw System, Smith & Nephew * K000684, Small Fragment DCL System, Synthes * K013248, LCP Distal Tibial Plates, Synthes · K080522, LCP Distal Tibial T-plates, Synthes DEVICE DESCRIPTION: The two and four-hole plates feature a contoured mid-section and low p… | 2008 |
What descends from it? (15)
See all 152 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 10 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K100240 (OrthoPediatrics Corp., 2010) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K081407.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PediPlateTM system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip…
Read the full statement (149 words)
The OrthoPediatrics PediPlateTM system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis.
Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, 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/K090666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090666: Pediplates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090666
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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