510(k) · Cleared
ClearedOrthoPediatrics PediFoot Deformity Corrections 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 Aug 6, 2019 as substantially equivalent to K050110 (Synthes (Usa), 2005) and 4 other predicates after a 113-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Aug 6, 2019
- Review
- 113 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962616 (1996). 100 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK190992 OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp. · 2019
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 1 generation backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- This deviceK190992 OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −2 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| 0 (this device) | K190992 | OrthoPediatrics PediFoot Deformity Corrections System | OrthoPediatrics Corp. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K050110 | Synthes (Usa) LCP Modular Foot PlatesSummary page 4…Code: HRS Common Name: Plate, Fixation, Bone Legally marketed devices to which substantial equivalence is claimed: Primary Predicate: • K050110 – Synthes LCP Modular Foot Plates Secondary Predicates: • K063049 – Synthes Modular Mini Fragment LCP System • K10077… | 2005 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…ally marketed devices to which substantial equivalence is claimed: Primary Predicate: • K050110 – Synthes LCP Modular Foot Plates Secondary Predicates: • K063049 – Synthes Modular Mini Fragment LCP System • K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)‐LCP Forefoot/Midfoot System… | 2006 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 4…claimed: Primary Predicate: • K050110 – Synthes LCP Modular Foot Plates Secondary Predicates: • K063049 – Synthes Modular Mini Fragment LCP System • K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)‐LCP Forefoot/Midfoot System • K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/… | 2010 |
| * | K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSummary page 4…Secondary Predicates: • K063049 – Synthes Modular Mini Fragment LCP System • K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)‐LCP Forefoot/Midfoot System • K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot • K001941 – Synthes Modular Foot System Device Description The OrthoP… | 2013 |
| * | K001941 | Synthes Modular Foot SystemSummary page 4…LCP System • K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)‐LCP Forefoot/Midfoot System • K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot • K001941 – Synthes Modular Foot System Device Description The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 100 ancestors have a recall of any class.
- 6 other devices also cite its predicate K050110.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190992: OrthoPediatrics PediFoot Deformity Corrections System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190992
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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