510(k) · Cleared
Recalled · Class II · 2015Orthopediatrics Fracture and Osteotomy Bone Plate 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 Jun 17, 2011 as substantially equivalent to K062872 (Synthes (Usa), 2007) and 6 other predicates after a 59-day review. Its family tree reaches back 9 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 9 generations to K962616 (1996). 63 ancestors in all, the oldest K862157 (1986). 7 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 1 generation backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- This deviceK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011
- Descendant · cites it directly · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016
- Descendant · cites it directly · 1 of its ownK140431 Pediloc Fragment SystemOrthoPediatrics Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK252600 Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025
- Descendant · cites it directly · 0 of its ownK243963 Pediatric Plating Platform HipOrthoPediatrics Corp. · 2025
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 1 generation backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- This deviceK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · cites it directly2descendants
- K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · cites it directly1descendant
- K140431Pediloc Fragment SystemOrthoPediatrics Corp. · 2014 · cites it directly1descendant
- K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025 · 2 generations on0descendants
- K243963Pediatric Plating Platform HipOrthoPediatrics Corp. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −1 | K100240 | Orthopediatrics Pediloc Tibia Plate System | OrthoPediatrics Corp. | 2010 | — |
| 0 (this device) | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | — |
| +1 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +1 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | OrthoPediatrics Corp. | 2016 | — |
| +1 | K140431 | Pediloc Fragment System | OrthoPediatrics Corp. | 2014 | — |
| +2 | K252600 | Pediatric Plating Platform I Small-Mini | OrthoPediatrics Corp. | 2025 | — |
| +1 | K243963 | Pediatric Plating Platform Hip | OrthoPediatrics Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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 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? (7)
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 2…ions include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomnies. PREDICATE DEVICES: K062872, Pediatric LCP Hip Plate System, Synthes (USA) K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA) K083286, Pedi… | 2007 |
| * | K072095 | Synthes (Usa) Pediatric LCP Hip Plate System ModificationsSummary page 2…teotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomnies. PREDICATE DEVICES: K062872, Pediatric LCP Hip Plate System, Synthes (USA) K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA) K083286, PediLoc Locking Plate System, Orthopediatrics K082949, Orth… | 2007 |
| * | K083286 | Orthopediatrics Pediloc Locking Plate SystemSummary page 2…ric valgus osteotomnies. PREDICATE DEVICES: K062872, Pediatric LCP Hip Plate System, Synthes (USA) K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA) K083286, PediLoc Locking Plate System, Orthopediatrics K082949, Orthoediatrics Bone Screws, Orthoediatrics K100240, PediLoc Tibial Plate… | 2009 |
| * | K082949 | Orthopediatrics Bone ScrewsSummary page 2…Pediatric LCP Hip Plate System, Synthes (USA) K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA) K083286, PediLoc Locking Plate System, Orthopediatrics K082949, Orthoediatrics Bone Screws, Orthoediatrics K100240, PediLoc Tibial Plate System, Orthoeiatrics K070906, Periarticular Locking Pl… | 2008 |
| * | K100240 | Orthopediatrics Pediloc Tibia Plate SystemSummary page 2…5, Pediatric LCP Hip Plate System Modifications, Synthes (USA) K083286, PediLoc Locking Plate System, Orthopediatrics K082949, Orthoediatrics Bone Screws, Orthoediatrics K100240, PediLoc Tibial Plate System, Orthoeiatrics K070906, Periarticular Locking Plate System, Zimmer K003496, Cannulated Screw System,… | 2010 |
| * | K070906 | Modificaton to: Zimmer Periarticular Locking Plates and ScrewsSummary page 2…thes (USA) K083286, PediLoc Locking Plate System, Orthopediatrics K082949, Orthoediatrics Bone Screws, Orthoediatrics K100240, PediLoc Tibial Plate System, Orthoeiatrics K070906, Periarticular Locking Plate System, Zimmer K003496, Cannulated Screw System, Pioneer MATERIALS: All implant components are manu… | 2007 |
| * | K003496 | Cannulated Screw SystemSummary page 2…thopediatrics K082949, Orthoediatrics Bone Screws, Orthoediatrics K100240, PediLoc Tibial Plate System, Orthoeiatrics K070906, Periarticular Locking Plate System, Zimmer K003496, Cannulated Screw System, Pioneer MATERIALS: All implant components are manufactured from medical grade metals including 316L st… | 2001 |
What descends from it? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2015 | Class II | Z-2796-2015 | Packaging process control | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 63 ancestors have a recall of any class.
- Of its descendants, K192181 (Nuvasive Specialized Orthopedics, Inc., 2019) has gone furthest, with 2 descendants 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 Orthoediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111086
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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