510(k) · Cleared
ClearedOrthoPediatrics Titanium 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 Aug 24, 2017 as substantially equivalent to K093442 (Orthofix, Inc., 2010) after a 125-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Aug 24, 2017
- Review
- 125 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031493 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
- 1 generation backK093442 Guided Growth SystemOrthofix, Inc. · 2010
- This deviceK171173 OrthoPediatrics Titanium PediPlates® SystemOrthoPediatrics Corp. · 2017
- Descendant · cites it directly · 0 of its ownK182704 WishBone Guided Growth SystemWishbone Medical · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K182704WishBone Guided Growth SystemWishbone Medical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031493 | Growth Guidance Plate | University of Utah/School of Medicine | 2003 | — |
| −1 | K093442 | Guided Growth System | Orthofix, Inc. | 2010 | — |
| 0 (this device) | K171173 | OrthoPediatrics Titanium PediPlates® System | OrthoPediatrics Corp. | 2017 | — |
| +1 | K182704 | WishBone Guided Growth System | Wishbone Medical | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (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 |
|---|---|---|---|
| * | K093442 | Guided Growth SystemSummary page 4… Screw,Fixation,Bone Legallymarketeddevicestowhichsubstantialequivalenceisclaimed: x K093442–OrthofixGuidedGrowthSystem DeviceDescription TheOrthoPediatricsTitaniumPediPlates®Systemconsistsoftwoandfou… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182704 | WishBone Guided Growth System | 2019 | 0 |
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 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182704 (Wishbone Medical, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K093442.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device 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/K171173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171173: OrthoPediatrics Titanium PediPlates® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171173
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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