Epiphyseal Plate Instruments Set – 1.5 mm Wire-Guided Cannulated Fixation

Epiphyseal Plate Instruments Set, SKU PS-OP-02683, is a 25-piece reusable pediatric orthopedic instrumentation system manufactured from German stainless steel for temporary hemiepiphysiodesis and guided-growth plate fixation across an active physis. The set contains small and large terrace-shaped aiming devices, small and large arc-bridge aiming devices, two detachable aiming handles, two Ø1.5 × 3.0 mm cannulated fixation bolts, three Ø1.5 × 150 mm guide wires, two Ø1.5 × 3.0 mm wire drill sleeves, a guide-wire depth gauge, two Ø6.1 × 7.3 mm protective drill sleeves, two Ø1.5 × 3.0 × 200 mm cannulated drill bits, two Ø3.0 × 6.1 mm screw-hole sleeves, screw forceps, a cannulated Ø3.0 mm hexagonal screwdriver, a Ø2.5 mm fixation-sleeve wrench, and a dedicated container. These instruments support plate positioning, wire placement, measured cannulated drilling, screw transfer, and controlled insertion during correction of genu valgum, genu varum, ankle valgus, sagittal knee deformity, and selected cubitus varus in skeletally immature patients. Pediatric orthopedic surgeons and limb-reconstruction specialists use the system in children’s hospitals, orthopedic operating rooms, and reconstructive surgery centers where image-guided physeal modulation is performed.

Guided Alignment and Cannulated Drilling Mechanism

The system works as a coaxial targeting sequence rather than an unguided plate-and-screw tray. A terrace-shaped or arc-bridge aiming device seats against the corresponding implant profile and establishes the intended screw axis on the epiphyseal and metaphyseal sides of the growth plate. Its detachable handle provides leverage for positioning through a limited incision while keeping the operator’s hand outside the fluoroscopic field. The cannulated fixation bolt couples the selected guide to the plate, preventing rotational drift during wire placement. A Ø1.5 mm guide wire passes through the matched sleeve to define trajectory and preserve alignment when imaging confirms its relation to the physis and joint surface. The depth gauge reads wire penetration for screw-length planning. The Ø6.1 × 7.3 mm sleeve forms a protective portal for powered drilling, while the long cannulated bit advances concentrically over the established wire. The Ø3.0 × 6.1 mm sleeve centers preparation of the screw hole and limits lateral skiving. Screw forceps control implant transfer at the wound, and the cannulated 3.0 mm hex driver follows the wire during insertion. The 2.5 mm wrench engages the fixation sleeve for assembly, tightening, and release without disturbing the targeted orientation.

Temporary Hemiepiphysiodesis Workflow by Anatomical Site

During guided-growth correction, the surgeon localizes the physis fluoroscopically and positions a terrace or arc-bridge plate across one side of the growth plate without crossing it with the plate body. At the distal femur or proximal tibia, medial placement addresses genu valgum and lateral placement addresses genu varum; anterior or posterior constructs can be used for selected sagittal-plane knee deformities according to the operative plan. At the distal tibia, the same wire-directed sequence supports medial hemiepiphysiodesis for ankle valgus. Around the distal humerus, the compact configuration can assist selected pediatric angular correction when the approved implant geometry and approach correspond. After the chosen aimer is fixed to the plate, one 1.5 mm wire establishes the epiphyseal trajectory and another establishes the metaphyseal path. Fluoroscopy confirms that both paths respect the joint and physis before measurement and drilling. The gauge establishes required depth, the cannulated bit prepares each track through the protection sleeve, and the forceps present the screw to the plate aperture. Final advancement with the 3.0 mm hex driver seats the screws while allowing controlled divergence as the plate acts as an extraperiosteal tension band. The same driver supports later implant removal once correction has reached the planned endpoint.

Instrument Selection Across the 25-Piece Configuration

PS-2000.001 and PS-2000.007 are the small and large terrace aimers, selected for the corresponding stepped plate profile and operative footprint. PS-2000.013 and PS-2000.019 provide small and large arc-bridge interfaces where the raised central geometry must clear the physis. The paired PS-2000.025 handles attach to either guide for manipulation. PS-2000.031 secures an aimer through its Ø1.5 × 3.0 mm cannulated fixation bolt. Three PS-2000.037 wires, each Ø1.5 × 150 mm, establish provisional axes and retain one sterile backup. PS-2000.043 centers those wires through a Ø1.5 × 3.0 mm bore, while PS-2000.049 measures their depth. PS-2000.055 protects the exposure around a Ø6.1 × 7.3 mm drilling portal. PS-2000.061 provides two 200 mm cannulated bits sized Ø1.5 × 3.0 mm for over-wire bone preparation. PS-2000.067 directs the bit at screw holes through its Ø3.0 × 6.1 mm lumen. PS-2000.073 grips and presents the screw without finger placement in the incision. PS-2000.079 is the Ø3.0 mm cannulated hex driver used over the retained guide. PS-2000.085 is the Ø2.5 mm wrench for the fixation sleeve. PS-2000.091 organizes the complete system for storage, transport, counting, and reprocessing.

German Stainless Steel, Reprocessing, and Procurement Controls

German stainless steel provides the hardness, torsional resistance, corrosion control, and dimensional stability required for reusable aimers, sleeves, wires, drills, forceps, and drivers exposed to repeated orthopedic instrument cycles. The satin finish reduces operating-light reflection and allows visual inspection for soil, staining, fretting, drill-flute damage, or cannulation obstruction. This set is supplied as reusable, non-sterile instrumentation. After surgery, staff should prevent soil from drying, disassemble detachable connections, flush every bore, clean using the validated manual or automated process, rinse, dry, inspect, function-test, package in the dedicated container, and steam sterilize under the healthcare facility’s validated protocol and the applicable instructions for use. Lumens require particular attention because retained debris can compromise wire passage and sterilant contact. CE documentation supports applicable European conformity requirements, while ISO 13485 identifies the manufacturer’s medical-device quality-management framework. For United States procurement, FDA status is assessed through the applicable establishment registration, device listing, labeling, importer, and product-classification documentation; CE marking and ISO certification do not constitute FDA approval. Hospitals and distributors should retain the supplied declarations, lot or batch traceability, reprocessing instructions, warranty terms, and purchase records within their vendor-qualification file.

Products Specifications 

How does this set differ from a standard small-fragment locking plate instrument set?
A standard small-fragment locking plate tray uses fixed-angle guides, conventional taps, and locking drivers for fracture stabilization without a growth-guidance target. The Epiphyseal Plate Instruments Set combines terrace and arc-bridge aimers that interface with plate profiles spanning one side of a physis. Its 1.5 mm wire establishes trajectory before the 3.0 mm cannulated bit follows the same axis. The protective sleeve shields the surgical corridor, while the cannulated hex driver advances a compatible screw over the retained wire. This configuration is selected for temporary hemiepiphysiodesis rather than routine metaphyseal fracture plating. Implant and screw pairing must follow the approved system documentation.

How are the small and large terrace and arc-bridge aiming devices selected?
In the Epiphyseal Plate Instruments Set, small aimers suit compact operative windows and limited plate footprints, including distal tibial or distal humeral guided-growth exposure. Large aimers provide a broader interface for the distal femur or proximal tibia when the selected implant has the larger matching profile. Terrace geometry follows a stepped plate surface, whereas the arc-bridge form accommodates a raised central span over the physis. The 1.5 mm wire and matching sleeve maintain the planned screw axis regardless of guide size. The depth gauge then supports screw-length selection after fluoroscopic confirmation. Plate pattern, physeal width, bone contour, approach, and approved implant pairing determine the final choice.

What do CE, ISO 13485, and FDA status mean for procurement?
The Epiphyseal Plate Instruments Set is supplied for procurement under the manufacturer’s stated CE and ISO 13485 framework. CE marking addresses applicable European conformity requirements for the device and its documentation. ISO 13485 concerns the medical-device quality-management system used for controlled production and traceability. Neither designation is the same as FDA approval. United States buyers assess establishment registration, device listing, product classification, labeling, importer records, and any required premarket pathway. Procurement teams should retain current declarations, certificates, device records, and supplier qualification documents with the purchase file.

How do the fixation bolt, sleeves, and cannulated controls work intraoperatively?
The detachable handle positions the selected aimer against the compatible plate profile. A cannulated fixation bolt locks that guide-to-plate relationship so the targeting axis does not rotate during wire passage. The 1.5 mm wire sleeve constrains the trocar-tipped wire, and fluoroscopy confirms its epiphyseal or metaphyseal path. After depth measurement, the 6.1 × 7.3 mm protection sleeve isolates the working corridor while the long drill follows the wire. The screw-hole sleeve limits lateral drift at the plate aperture, and the 3.0 mm cannulated hex driver advances the screw coaxially. The 2.5 mm wrench tightens or releases the fixation sleeve before the targeting assembly is removed.

What should hospitals order and reprocess with this 25-piece system?
The Epiphyseal Plate Instruments Set should be received against the 16 component codes and 25 total units shown in the composition table. Operating-room supply staff should check aimers, paired handles, bolts, wires, sleeves, drills, forceps, driver, wrench, and container before release. The instruments are reusable and supplied non-sterile. Central sterile staff should disassemble connections, flush cannulations, clean, rinse, dry, inspect, package, and steam sterilize under the validated facility cycle and applicable instructions for use. Missing wires, damaged drill edges, obstructed lumens, or worn driver interfaces require removal from service and replacement. Distributors can request OEM labeling, code mapping, custom tray configuration, and supporting commercial documentation for qualified orders.