Orthopediatrics Canada ULC
Laval Quebec, CA
ORTHOPEDIATRICS CANADA ULC appears in FDA device records in Laval Quebec, CA. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Orthopediatrics Canada ULC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Orthopediatrics Canada Ulc Dba Pega Medical510(k), enforcement report, recall
- Pega Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 13 510(k) clearances for Orthopediatrics Canada ULC between 2003 and 2025. The busiest year on record is 2017, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241983 | Fassier-Duval Telescoping IM System | HSB | Substantially Equivalent | |
| K220190 | The GIRO Growth Modulation System | OBT | Substantially Equivalent | |
| K211292 | Fassier-Duval Telescopic IM System | HSB | Substantially Equivalent | |
| K192710 | The Simple Locking Intramedullary (Slim) System | HSB | Substantially Equivalent | |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | KTT | Substantially Equivalent | |
| K163003 | Y3 Proximal Femoral Plate System | HRS | Substantially Equivalent | |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | Substantially Equivalent | |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | HSB | Substantially Equivalent | |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | HWC | Substantially Equivalent | |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | Substantially Equivalent | |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | HRS | Substantially Equivalent | |
| K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | HSB | Substantially Equivalent | |
| K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM | HSB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000327445 | 3000327445 | ORTHOPEDIATRICS CANADA ULC | 1111 Chomedey Highway (A13), Laval Quebec H7W 5J8 CA | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HWJAwl
- HTWBit, Drill
- LYSBone Mill
- HXZCutter, Wire
- HWBExtractor
- HTJGauge, Depth
- LXHOrthopedic Manual Surgical Instrument
- HXIPasser, Wire, Orthopedic
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis
- HRSPlate, Fixation, Bone
- HTOReamer
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HWKTrephine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2941-2024 | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System | 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. | Class II | Open, Classified | |
| Z-2038-2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. | Class III | Terminated | |
| Z-0270-2020 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. | Class II | Terminated | |
| Z-2278-2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System | Handle could jam with the Driver due to the detachment of an internal Connector Ring. | Class II | Terminated | |
| Z-0324-2016 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic. | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. | Class II | Terminated | |
| Z-1848-2015 | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. | Class II | Terminated | |
| Z-1546-2015 | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number. | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage. | Class II | Terminated | |
| Z-1362-2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes. | Class II | Terminated | |
| Z-1472-2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. | The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. | Class II | Terminated | |
| Z-1448-2014 | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. | The Male Components in this lot are made of material with lower strength than manufacturing specifications. | Class II | Terminated | |
| Z-1494-2011 | Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. | Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain