510(k) · Cleared
ClearedGrowth Control Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Trauma · HRS Plate, Fixation, Bone
Cleared on May 7, 2007 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) after a 42-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- May 7, 2007
- Review
- 42 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031493 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031493 Growth Guidance PlateUniversity of Utah/School of Medicine · 2003
- This deviceK070823 Growth Control Plating SystemBiomet Trauma · 2007
- Descendant · cites it directly · 1 of its ownK090440 Hinge Pediatric Plating SystemPega Medical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK220190 The GIRO Growth Modulation SystemPega Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK093880 Peanut Growth Control Plating SystemEbi, L.P. · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031493 | Growth Guidance Plate | University of Utah/School of Medicine | 2003 | — |
| 0 (this device) | K070823 | Growth Control Plating System | Biomet Trauma | 2007 | — |
| +1 | K090440 | Hinge Pediatric Plating System | Pega Medical, Inc. | 2009 | — |
| +2 | K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022 | — |
| +1 | K093880 | Peanut Growth Control Plating System | Ebi, L.P. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K031493 | Growth Guidance PlateSummary page 1…s and accessories, 21 CFR §888.3030, HRS Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Guided Growth Plate K031493 University of Utah School of Medicine Device Description: The Growth Control Plating System consists of plates and screws, all of… | 2003 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting angular deformities in pediatric patients with an open physis. 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, as well as 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/K070823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070823: Growth Control Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070823
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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