510(k) · Cleared
ClearedPediloc Fragment 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 Jul 29, 2014 as substantially equivalent to K111086 (OrthoPediatrics Corp., 2011) and 3 other predicates after a 159-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Jul 29, 2014
- Review
- 159 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K962616 (1996). 64 ancestors in all, the oldest K862157 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- 1 generation backK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- This deviceK140431 Pediloc Fragment SystemOrthoPediatrics Corp. · 2014
- Descendant · cites it directly · 0 of its ownK252600 Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025
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 backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
- 1 generation backK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- This deviceK140431 Pediloc Fragment SystemOrthoPediatrics Corp. · 2014
Most influential descendants
Showing 1 of 1 · See all- K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025 · cites it directly0descendants
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 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −2 | K100240 | Orthopediatrics Pediloc Tibia Plate System | OrthoPediatrics Corp. | 2010 | — |
| −1 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| 0 (this device) | K140431 | Pediloc Fragment System | OrthoPediatrics Corp. | 2014 | — |
| +1 | K252600 | Pediatric Plating Platform I Small-Mini | 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 |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate SystemSummary page 1…Steel Medical grade cobalt-chromium-molybdenumn PREDICATE DEVICES: OrthoPediatrics Fracture and Osteotomy Bone Plate System (K1 11086) OrthoPediatrics PediLoc Locking Plate System (K083286) OrthoPediatrics Bone Screws (K0… | 2011 |
| * | K083286 | Orthopediatrics Pediloc Locking Plate SystemSummary page 1…TE DEVICES: OrthoPediatrics Fracture and Osteotomy Bone Plate System (K1 11086) OrthoPediatrics PediLoc Locking Plate System (K083286) OrthoPediatrics Bone Screws (K082949) Synthes Small Fragment Dynamic Compression Locki… | 2009 |
| * | K082949 | Orthopediatrics Bone ScrewsSummary page 1…late System (K1 11086) OrthoPediatrics PediLoc Locking Plate System (K083286) OrthoPediatrics Bone Screws (K082949) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) === Page 2… | 2008 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…86) OrthoPediatrics Bone Screws (K082949) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) K140431 - page 2of 2 TECHNOLOGIC… | 2000 |
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 |
|---|---|---|---|
| K252600 | Pediatric Plating Platform I Small-Mini | 2025 | 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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 64 ancestors have a recall of any class.
- Of its descendants, K252600 (OrthoPediatrics Corp., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111086.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
OrthoPedlatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvs, and scapula. This Includes fractures, osteotomles, mal-unlons, and non-unions in all pediatric subgroups (except neonates), and small stature adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140431: Pediloc Fragment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140431
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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