Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

OrthoPediatrics medical devices: approvals, recalls and adverse events

Stock: KIDS. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

0 class I

Adverse event reports

778

- deaths reported

How many recalls does OrthoPediatrics have?

OrthoPediatrics has 53 recalled medical device products in 23 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Jul 4, 2024. In 2022 it had 2 recalled products.

How many medical devices has OrthoPediatrics had cleared or approved?

45 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Apr 30, 2026.

How many adverse event reports name OrthoPediatrics devices?

778 reports in total: - deaths, 208 injuries and 568 malfunctions were reported. 96 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	1	0	0	0
2025	7	0	0	0
2024	1	0	0	0
2023

Newest clearances and approvals

OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · 510(k) clearance · Apr 30, 2026
Pediatric Plating Platform I Small-Mini
K252600 · 510(k) clearance · Oct 9, 2025
PediFlex Flexible Nail System
K251362 · 510(k) clearance · Jun 24, 2025
Pediatric Plating Platform Hip
K243963 · 510(k) clearance · Apr 29, 2025
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
K250623 · 510(k) clearance · Apr 1, 2025
VerteGlide Spinal Growth Guidance System
K241816 · 510(k) clearance · Mar 14, 2025
Orthex External Fixation System
K243798 · 510(k) clearance · Mar 7, 2025
Fassier-Duval Telescoping IM System
K241983 · 510(k) clearance · Feb 21, 2025
RESPONSE Rib and Pelvic System
K233105 · 510(k) clearance · Jan 20, 2024
Pediatric Nailing Platform Tibia
K231266 · 510(k) clearance · Aug 21, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · 510(k) clearance · Mar 23, 2023
Orthex External Fixation System

Devices with the most adverse event reports

By product code, all years

Screw, Fixation, Bone (HWC, class 2)177
Thoracolumbosacral Pedicle Screw System (NKB, class 2)162
Plate, Fixation, Bone (HRS, class 2)139
Rod, Fixation, Intramedullary And Accessories (HSB, class 2)91
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH, class 2)39
Bit, Drill (HTW, class 1)33
Pin, Fixation, Threaded (JDW, class 2)23
Bit, Surgical (GFG, class 1)16
Appliance, Fixation, Spinal Interlaminal (KWP, class 2)13

All device makers and procedures · KIDS stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to KIDS with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	0	49	-
2025	0	96	-
2024	1	84	-
2023	0	45	-
2022	2	48	-
2021	0	93	-
2020	3	148	-
2019	3	50	-
2018	0	74	-
2017	2	32	-
2016	3	10	-
2015	2	9	-
2014	2	13	-
2013	6	15	-
2012	3	9	-

Newest recalls

FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Class II · Jul 4, 2024 · During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
Orthex Large Bone Shoulder Bolt, model no. AS-17
Class II · Sep 12, 2022 · Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruptio
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Class II · Jun 29, 2022 · Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieva
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of
Class II · Jul 6, 2020 · Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixatio
Class II · Jun 5, 2020 · ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-10
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixatio
Class II · Jun 5, 2020 · ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-10
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant
Class II · Aug 19, 2019 · Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant syste
Class II · Aug 19, 2019 · Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant s
Class II · Aug 19, 2019 · Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Class II · Aug 3, 2017 · The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.