510(k) · Cleared
ClearedSynthes LCP Pediatric Plate Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Nov 17, 2011 as substantially equivalent to K062872 (Synthes (Usa), 2007) and 3 other predicates after a 119-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- Nov 17, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K981372 (1998). 16 ancestors in all, the oldest K914546 (1991). 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- This deviceK112085 Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 1 of its ownK200246 JPS JuniOrtho Plating SystemOrthofix Srl · 2020
- Descendant · cites it directly · 0 of its ownK230527 WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK213572 JuniOrtho Plating System™Orthofix Srl · 2022
- Descendant · cites it directly · 0 of its ownK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K200246JPS JuniOrtho Plating SystemOrthofix Srl · 2020 · cites it directly1descendant
- K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc. · 2023 · cites it directly0descendants
- K213572JuniOrtho Plating System™Orthofix Srl · 2022 · cites it directly0descendants
- K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −1 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| 0 (this device) | K112085 | Synthes LCP Pediatric Plate Systems | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K200246 | JPS JuniOrtho Plating System | Orthofix Srl | 2020 | — |
| +1 | K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2023 | — |
| +1 | K213572 | JuniOrtho Plating System™ | Orthofix Srl | 2022 | — |
| +1 | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K062872 | Synthes (Usa) Pediatric LCP Hip Plate SystemSummary page 1…[[, §888.3030, Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095) Synthes Angled Blade Plates (Pre-amendment, K914546) Synthes 3.5mm Curved LCP Plates (K092609) Device Description: Th… | 2007 |
| * | K072095 | Synthes (Usa) Pediatric LCP Hip Plate System ModificationsSummary page 1….3030, Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095) Synthes Angled Blade Plates (Pre-amendment, K914546) Synthes 3.5mm Curved LCP Plates (K092609) Device Description: The system… | 2007 |
| * | K914546 | Angled Blade PlateSummary page 1…ion appliances and accessories. Product Code: HRS Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095) Synthes Angled Blade Plates (Pre-amendment, K914546) Synthes 3.5mm Curved LCP Plates (K092609) Device Description: The system is a collection of plates used to treat fractures and… | 1991 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 1…ode: HRS Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095) Synthes Angled Blade Plates (Pre-amendment, K914546) Synthes 3.5mm Curved LCP Plates (K092609) Device Description: The system is a collection of plates used to treat fractures and osteotomies of the femur in infants, chil… | 2009 |
What descends from it? (4)
4 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 13 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K200246 (Orthofix Srl, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K062872.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults. Specific indications for the 100°, 110°, 120° 130°. 140° 150° plates include: Varus, valgus, rotational and/or shortening osteotomies Femoral neck and/or pertrochanteric fractures Proximal metaphyseal fractures Diaphyseal…
Read the full statement (101 words)
The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.
Specific indications for the 100°, 110°, 120° 130°. 140° 150° plates include:
Varus, valgus, rotational and/or shortening osteotomies
Femoral neck and/or pertrochanteric fractures
Proximal metaphyseal fractures
Diaphyseal fractures
Pathologic fractures
Prophylactic use for impending pathologic fractures
Specific indications for the 90° plates include:
Varus, valgus, rotational and/or shortening osteotomies
Femoral neck and/or pertrochanteric fractures
Proximal and distal metaphyseal fractures
Diaphyseal fractures
Pathologic fractures
Prophylactic use for impending pathologic fractures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112085: Synthes LCP Pediatric Plate Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112085
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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