510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Orthopediatrics Pediloc Locking Plate System

K083286510(k) TraditionalCleared Jan 30, 200986-day reviewClass II21 CFR 888.3030Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

OrthoPediatrics Corp. · HRS Plate, Fixation, Bone

Cleared on Jan 30, 2009 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 4 other predicates after an 86-day review. Its family tree reaches back 7 generations to 1996. 60 later devices descend from it. It has been recalled 5 times.

Decided
Jan 30, 2009
Review
86 days
Class
Class II
Product code
HRS
Recalls
5
Predicates
5

Its longest line of descent runs back 7 generations to K962616 (1996). 35 ancestors in all, the oldest K890939 (1989). 60 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 3 other ancestors2006: 1 other ancestor2003: 2 other ancestors2005: 1 other ancestor2004: 3 other ancestors2001: 4 other ancestors2000: 6 other ancestors1999: 2 other ancestors1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1996: 1 other ancestor2011: 2 descendants cleared2019: 4 descendants cleared2014: 1 descendant cleared2012: 1 descendant cleared2010: 2 descendants cleared2017: 6 descendants cleared2022: 3 descendants cleared2020: 6 descendants cleared2026: 6 descendants cleared2025: 8 descendants cleared2016: 1 descendant cleared2023: 5 descendants cleared2015: 1 descendant cleared2018: 3 descendants cleared2024: 10 descendants cleared2021: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 13 other ancestors3 generations back: 9 other ancestors6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 20 descendants3 generations forward: 19 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50+5
  1. Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. This deviceK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009
  9. Descendant · cites it directly · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  10. Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  11. Descendant · cites it directly · 13 of its ownK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
  12. Descendant · cites it directly · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  13. Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2010: 22011: 22012: 12014: 12015: 12016: 12017: 62018: 32019: 42020: 62021: 12022: 32023: 52024: 102025: 82026: 6
2010high 10 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 60 · See all
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · cites it directly28descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
  • K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010 · cites it directly13descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−6K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−5K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−4K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−2K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
0 (this device)K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009—
+1K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC2012—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+1K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.2010—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199610
199820
199920
200060
200140
200320
200430
200510
200610
200830

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201120
201210
201410
201510
201610
201760
201830
201940
202060
202110
202230
202350
2024100
202580
202660
FIG. 1 — Lineage of K083286, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Summary page 1
…Class IIper 21 CFR §888.3030 DEVICE PRODUCT CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K0…
Smith & Nephew, Inc.20031
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 1
…CODE(S): HRS and HWC SUBSTANTIALLY EQUIVALENT DEVICES: S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate…
Smith & Nephew, Inc.2005—
*K073344Orthopediatrics Plating System
Summary page 1
…DEVICES: S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA) DEVICE DESCRIPTION: A pe…
Orthopediatrics, LLC2008—
*K081407Orthopediatrics Pediplates System
Summary page 1
…S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA) DEVICE DESCRIPTION: A pediatric s…
OrthoPediatrics Corp.2008—
*K062564Synthes LCP Distal Femur Plates
Summary page 1
…cking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA) DEVICE DESCRIPTION: A pediatric small fragment set offers advantages of both conventional and locking plate fix…
Synthes (Usa)2006—

Also cleared against K033669: 27 other devices →

What descends from it? (60)

See all 60

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013
K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711
K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.20117
K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.20112
K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141
K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190
K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 27, 2016Class IIZ-2844-2016Labeling mix-upsOrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Jul 27, 2016Class IIZ-2843-2016Labeling mix-upsOrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Jul 24, 2013Class IIZ-1941-2013Process designOrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong…
Oct 18, 2012Class IIZ-0432-2013Nonconforming Material/ComponentComplaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not…
Jun 14, 2012Class IIZ-2057-2012Error in labelingThe device is a Left 8 hole plate but is incorrectly labeled and etched as a Right 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 5 companies; a new generation was cleared every 1.6 years on median.
  • 7 of the 35 ancestors have a recall of any class.
  • Of its descendants, K120689 (Synthes (USA) Products, LLC, 2012) has gone furthest, with 28 descendants of its own.
  • 27 other devices also cite its predicate K033669.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The OrthoPediatrics PediLocTM Locking Plate System is used for pediatric

patients as indicated for pelvic, small and long bone fractures, including those of

the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus,

ulna, radius, calcaneus, and clavicle. Indications for buttressing multi-

fragmentary distal femoral fractures include: supracondylar, intra-articular and

extra-articular condylar, periprosthetic fractures and fractures in normal or

osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.

Indications for use as stated in the FDA summary.

Also cleared against K033669

27 other devices cite the same predicate.

  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  • K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 20204 recalls
  • K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
  • K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. · 2017

More from OrthoPediatrics Corp.

41 FDA decisions under this applicant name. See the company

  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp. · 2026
  • K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp. · 2025
  • K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp. · 2025
  • K243963Pediatric Plating Platform HipOrthoPediatrics Corp. · 2025

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K083286 · printed Nov 3, 2026

Cite this page

510(k) Report. “K083286: Orthopediatrics Pediloc Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083286

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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