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ORTHOPEDIATRICS CORP.

United States·US-MF-000001776

Last updated May 24, 2026

What ORTHOPEDIATRICS CORP. makes

Orthopaediatrics Corp. manufactures orthopaedic hardware for bone fixation, including non-sliding and non-bioabsorbable bone screws, intramedullary nails for the femur and tibia, and orthopaedic plates. Their portfolio also includes reusable surgical procedure kits, external fixation systems, and pediatric-specific devices like locking plates, screws, and intramedullary nailing platforms. Examples include the PediNail Intramedullary Platform for pediatric femur nailing, the SCFE screw for slipped capital femoral epiphysis, and the Response Spine System for spinal fixation.

The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIb, with corresponding entries in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 2850, Frontier Dr, Warsaw, United States
Website: www.orthopediatrics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(574) 268-6379
PRRC Contact: Yan Li
EUDAMED SRN: US-MF-000001776
FDA FEI Number: —
DUNS Number: 796416191

Catalogue (12790)

Page 14 of 256

Device	Model / Reference	Registries	Class	Status
Response Spine System	01-1600-0090	FDA UDI	Class I	Active
3P Hip System	00-3004-3115	FDA UDI	Class II	Active
Mpfl	01-1150-0070	FDA UDI	Class I	Active
Response 4.5/5.0 Spine System	00-1600-2770	FDA UDI	Class II	Active
Orthex	C350-M4-B	FDA UDI	Class II	Active
PediFrag	00-1005-5014	FDA UDI	Class II	Active
General Instrument	01-1500-035	FDA UDI	Class I	Active
General Instrument	01-1200-0062	FDA UDI	Class I	Active
Locking Proximal Femur Plate System	00-0907-4780	FDA UDI	Class II	Active
PNP Tibia	00-1510-9295-S	FDA UDI	Class II	Active
PNP Tibia	00-1510-8195-S	FDA UDI	Class II	Active
3P Hip System	00-3050-0098	FDA UDI	Class II	Active
3P Hip System	00-3035-0054	FDA UDI	Class II	Active
Response Spine	01-1003-8508	FDA UDI	Class II	Active
RESPONSE Spine	00-1003-5553	FDA UDI	Class II	Unknown
Orthopediatrics Cannulated Screw System	00-1402-5098	FDA UDI	Class II	Active
3P Hip System	00-3011-3244	FDA UDI	Class II	Active
Dynamic Femur Fracture Brace	NS-DF2B-0105	FDA UDI	Class I	Unknown
Response Spine System	00-1300-4530	FDA UDI	Class II	Active
Response Spine 5.5/6.0 System	00-1300-0645	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-2310	FDA UDI	Class II	Active
3P Hip System	00-3050-3100	FDA UDI	Class II	Active
Orthopediatrics Cannulated Screw System	00-1402-2126	FDA UDI	Class II	Active
PediLoc Locking Plate System	00-1050-2110	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-3305	FDA UDI	Class II	Active
3P Hip System	00-3065-3405	FDA UDI	Class II	Active
Gen II Cannulated Screws	00-1402-7360	FDA UDI	Class II	Active
Pediatric Nailing Platform \| Tibia	00-1510-8210	FDA UDI	Class II	Active
Response 4.5/5.0	00-1600-2890	FDA UDI	Class II	Active
OrthoPediatrics Cannulated Screw System	01-1400-2146	FDA UDI	Class II	Active
Orthex	C420-F3	FDA UDI	Class II	Active
PediFlex Advanced	01-1001-9020	FDA UDI	Class I	Active
Pediloc Locking Plate System	00-1065-4012	FDA UDI	Class II	Active
Locking Cannulated Blade Plate	01-1200-4101	FDA UDI	Class I	Active
Response 5.5/6.0	00-1750-3601	FDA UDI	Class II	Active
3P Hip System	00-3050-3084	FDA UDI	Class II	Active
OrthoPediatrics PediNail Intramedullary Nailing System	10-1500-083	FDA UDI	Class II	Active
General Instrument	01-1003-6079	FDA UDI	Class I	Active
PediLoc Locking Plate System	00-1050-4690	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-3836	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-2823	FDA UDI	Class II	Active
Orthex	R025-230	FDA UDI	Class II	Active
SCFE Screw	00-1071-5012	FDA UDI	Class II	Active
PediLoc Fragment System	00-1005-3822	FDA UDI	Class II	Active
OrthoPediatrics Cannulated Screw System	00-1400-2725	FDA UDI	Class II	Active
PediNail Intramedullary Platform	01-1501-0054	FDA UDI	Class I	Active
RESPONSE Spine	01-1003-9090	FDA UDI	Class I	Active
General Instrument	01-1010-0027	FDA UDI	Class I	Active
PNP Tibia	00-1510-7260-S	FDA UDI	Class II	Active
3P Hip System	00-3000-2000	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (52)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

OrthoPediatrics Corp. has 52 recall records spanning from July 21, 2009, to September 12, 2022, with statuses including open, classified, and terminated. The reasons cited involve mislabeling, manufacturing deviations from design specifications, incorrect screw dimensions, color-coding errors, potential nail fractures, and functional failures such as weld fractures, binding issues, and instrument malfunctions. Specific instances include incorrect screw lengths, drill guide incompatibilities, and packaging errors where wrong-sized components were included.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 12, 2022	Z-0277-2023	—	open, classified	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 disruption of bone regeneration.
Jun 29, 2022	Z-1678-2022	—	open, classified	Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
Jul 6, 2020	Z-2742-2020	—	open, classified	Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
Jun 5, 2020	Z-2538-2020	—	terminated	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 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Jun 5, 2020	Z-2539-2020	—	terminated	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 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Aug 19, 2019	Z-0125-2020	—	terminated	Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Aug 19, 2019	Z-0218-2020	—	terminated	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Aug 19, 2019	Z-0219-2020	—	terminated	Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Aug 3, 2017	Z-0597-2018	—	terminated	The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Apr 24, 2017	Z-2321-2017	—	terminated	Over-tensioning of the band resulting in damage to the band causing it to rupture
Nov 18, 2016	Z-0879-2017	—	terminated	Labeled as a 48mm Cortical Screw but measuring at 50mm
Jul 27, 2016	Z-2844-2016	—	terminated	OrthoPediatrics 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, 2016	Z-2843-2016	—	terminated	OrthoPediatrics 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.
Nov 10, 2015	Z-0622-2016	—	terminated	Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
Jul 28, 2015	Z-2796-2015	—	terminated	The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
Jul 25, 2014	Z-2560-2014	—	terminated	Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Jan 8, 2014	Z-0934-2014	—	terminated	OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
Nov 7, 2013	Z-0579-2014	—	terminated	Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Sep 26, 2013	Z-0276-2014	—	terminated	The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Jul 24, 2013	Z-1941-2013	—	terminated	OrthoPediatrics 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 size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
Apr 19, 2013	Z-1535-2013	—	terminated	Post 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, 2013	Z-1536-2013	—	terminated	Post 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, 2013	Z-1534-2013	—	terminated	Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Oct 18, 2012	Z-0432-2013	—	terminated	Complaint 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 function as intended.
Sep 13, 2012	Z-0207-2013	—	terminated	A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
Jun 14, 2012	Z-2057-2012	—	terminated	The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Jul 21, 2009	Z-0356-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0344-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0358-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0362-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0349-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0354-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0348-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-034-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0351-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0359-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0363-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0342-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0350-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0339-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0364-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0347-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0345-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0361-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0341-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0346-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0352-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0343-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0360-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0355-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0357-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.
Jul 21, 2009	Z-0353-2010	—	terminated	The potential exists for the nails to fracture during insertion of the nail.