510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Orthopediatrics Blade Plate System

K110959510(k) TraditionalCleared Aug 5, 2011122-day reviewClass II21 CFR 888.3030Recalls 3

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 Aug 5, 2011 as substantially equivalent to K083286 (OrthoPediatrics Corp., 2009) and 3 other predicates after a 122-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it. It has been recalled 3 times.

Decided
Aug 5, 2011
Review
122 days
Class
Class II
Product code
HRS
Recalls
3
Predicates
4

Its longest line of descent runs back 9 generations to K962616 (1996). 55 ancestors in all, the oldest K862157 (1986). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 4 other ancestors1999: 4 other ancestors2009: 1 other ancestor2006: 1 other ancestor2005: 3 other ancestors2003: 2 other ancestors2002: 2 other ancestors2001: 6 other ancestors2000: 8 other ancestors1996: 5 other ancestors2004: 3 other ancestors1990: 1 other ancestor1986: 1 other ancestor1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2017: 1 descendant cleared2026: 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) K083286 · Orthopediatrics Pediloc Locking Plate System · OrthoPediatrics Corp. · 2009 · recalledK100240 · Orthopediatrics Pediloc Tibia Plate System · OrthoPediatrics Corp. · 20101990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 16 other ancestors3 generations back: 17 other ancestors4 generations back: 9 other ancestors7 generations back: 1 other ancestor8 generations back: 1 other ancestor 1 generation forward: 2 descendants K100240 · Orthopediatrics Pediloc Tibia Plate System · OrthoPediatrics Corp. · 2010K083286 · Orthopediatrics Pediloc Locking Plate System · OrthoPediatrics Corp. · 2009 · recalledK051735 · 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
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  5. 1 generation backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
  6. This deviceK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011
  7. Descendant · cites it directly · 0 of its ownK260323 OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp. · 2026
  8. Descendant · cites it directly · 0 of its ownK170704 The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. · 2017
Show all 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  9. 1 generation backK100240 Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp. · 2010
  10. This deviceK110959 Orthopediatrics Blade Plate SystemOrthoPediatrics Corp. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp. · 2026 · cites it directly0descendants
  • K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.20095
−1K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.2010—
0 (this device)K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.2011—
+1K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026—
+1K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198910
199010
199110
199510
199650
199820
199940
200080
200160
200220
200320
200430
200530
200610
200840
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202610
FIG. 1 — Lineage of K110959, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K083286Orthopediatrics Pediloc Locking Plate System
Summary page 1
…040 Recommended Class: 11 DEVICE PRODUCT CODE(S): HIRS, (Plate, Fixation, Bone) HWC, (Screw, Fixation, Bone) SUBSTANTIALLY EQUIVALENT DEVICES: K083286, PediL-oc Locking Plate System, OrthoPediatrics K100240, PediL-oc Tibial Plate System, OrthoPediatrics K082949, OrthoPediatrics B…
OrthoPediatrics Corp.20095
*K100240Orthopediatrics Pediloc Tibia Plate System
Summary page 1
…(Plate, Fixation, Bone) HWC, (Screw, Fixation, Bone) SUBSTANTIALLY EQUIVALENT DEVICES: K083286, PediL-oc Locking Plate System, OrthoPediatrics K100240, PediL-oc Tibial Plate System, OrthoPediatrics K082949, OrthoPediatrics Bone Screws, OrthoPediatrics K993289,Bone Plate System (T…
OrthoPediatrics Corp.2010—
*K082949Orthopediatrics Bone Screws
Summary page 1
…Screw, Fixation, Bone) SUBSTANTIALLY EQUIVALENT DEVICES: K083286, PediL-oc Locking Plate System, OrthoPediatrics K100240, PediL-oc Tibial Plate System, OrthoPediatrics K082949, OrthoPediatrics Bone Screws, OrthoPediatrics K993289,Bone Plate System (TC-100 Plating System ) Blade Plates, Smith & N…
OrthoPediatrics Corp.2008—
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 1
…ES: K083286, PediL-oc Locking Plate System, OrthoPediatrics K100240, PediL-oc Tibial Plate System, OrthoPediatrics K082949, OrthoPediatrics Bone Screws, OrthoPediatrics K993289,Bone Plate System (TC-100 Plating System ) Blade Plates, Smith & Nephew Pre Ammendment - Osteotomy / Blade Plates, Smith…
Smith & Nephew, Inc.1999—
*—Pre Ammendment - Osteotomy / Blade Plates, Smith & Nephew
Named without a submission number
—

Also cleared against K083286: 8 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260
K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 19, 2013Class IIZ-1535-2013Device DesignPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Apr 19, 2013Class IIZ-1536-2013Device DesignPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Apr 19, 2013Class IIZ-1534-2013Device DesignPost Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

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.
  • 12 of the 55 ancestors have a recall of any class.
  • Of its descendants, K260323 (OrthoPediatrics Corp., 2026) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K083286.

How does its category compare?

All HRS devices

HRS 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

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 Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

Indications for use as stated in the FDA summary.

Also cleared against K083286

8 other devices cite the same predicate.

  • K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA · 2019
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  • K140431Pediloc Fragment SystemOrthoPediatrics Corp. · 2014
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  • K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 20111 recall

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/K110959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110959: Orthopediatrics Blade 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/K110959

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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