510(k) · Cleared
ClearedSynthes (Usa) Pediatric LCP Hip Plate System Modifications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDS Nail, Fixation, Bone
Cleared on Sep 27, 2007 after a 58-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Sep 27, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK072095 Synthes (Usa) Pediatric LCP Hip Plate System ModificationsSynthes (Usa) · 2007
- Descendant · cites it directly · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · cites it directly · 4 of its ownK112085 Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK200246 JPS JuniOrtho Plating SystemOrthofix Srl · 2020
- Descendant · 2 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly7descendants
- K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC · 2011 · cites it directly4descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
- K200246JPS JuniOrtho Plating SystemOrthofix Srl · 2020 · 2 generations on1descendant
- K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072095 | Synthes (Usa) Pediatric LCP Hip Plate System Modifications | Synthes (Usa) | 2007 | — |
| +1 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| +1 | K112085 | Synthes LCP Pediatric Plate Systems | Synthes (USA) Products, LLC | 2011 | — |
| +2 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +2 | K200246 | JPS JuniOrtho Plating System | Orthofix Srl | 2020 | — |
| +2 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | OrthoPediatrics Corp. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Synthes Pediatric LCP Hip Plate System Named without a submission number | |
| * | — | Synthes Angled Blade Plates Named without a submission number |
What descends from it? (13)
See all 133 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?
- Of its descendants, K111086 (OrthoPediatrics Corp., 2011) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JDS devicesJDS Nail, 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 · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
• intertrochanteric rotational and/or varus osteotomies
• femoral neck and/or pertrochanteric fractures
• intertrochanteric valgus osteotomies and/or rotational osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072095: Synthes (Usa) Pediatric LCP Hip Plate System Modifications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072095
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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