510(k) · Cleared
ClearedHinge Pediatric Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pega Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on May 20, 2009 as substantially equivalent to K031493 (University of Utah/School of Medicine, 2003) and 2 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- May 20, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K993106 (1999). 8 ancestors in all. 1 later device descends from it, 1 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 deviceK090440 Hinge Pediatric Plating SystemPega Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK220190 The GIRO Growth Modulation SystemPega Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220190The GIRO Growth Modulation SystemPega Medical, Inc. · 2022 · cites it directly0descendants
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) | K090440 | Hinge Pediatric Plating System | Pega Medical, Inc. | 2009 | — |
| +1 | K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031493 | Growth Guidance PlateSummary page 2…ng predicate devices: I. Guided Growth Plate (Ti alloy plate and screws) University of Utah School of Medicine marketed as Eight Plate, Orthofix Inc. (K031493) 2. Pediplates System (Stainless Steel plate and screws), Orthopediatrics Inc. (K081407) 3. Growth Control Plating System mark… | 2003 |
| * | K081407 | Orthopediatrics Pediplates SystemSummary page 2…iversity of Utah School of Medicine marketed as Eight Plate, Orthofix Inc. (K031493) 2. Pediplates System (Stainless Steel plate and screws), Orthopediatrics Inc. (K081407) 3. Growth Control Plating System marketed as Peanut Plate (Ti alloy plate and screws), Biomet Inc. (K070823) The intended us… | 2008 |
| * | K070823 | Growth Control Plating SystemSummary page 2…ainless Steel plate and screws), Orthopediatrics Inc. (K081407) 3. Growth Control Plating System marketed as Peanut Plate (Ti alloy plate and screws), Biomet Inc. (K070823) The intended uses of these devices are the same as the Hinge Pediatric Plating System Summary of Technologies: The technologic… | 2007 |
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 |
|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | 2022 | 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 10 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K220190 (Pega Medical, Inc., 2022) has gone furthest, with 0 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. 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 Hinge Pediatric Plating System is indicated as a temporary implant to aid in the correction of the angle of growth of long bones by inhibiting longitudinal growth of the physis in pediatric patients. It can be used to correct the following conditions:
* Femur and tibia: varus, valgus, flexion or extension deformities of the knee.
* Humerus: valgus or varus deformities of the elbow.
* Radius and Ulna: flexion or extension deformities of the wrist.
* Ankle: varus, valgus or plantar flexion deformities of the ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090440: Hinge Pediatric Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090440
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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