Condylar Plate 95 Degree Specification, Uses, Sizes and Surgical Techniques

Condylar Plate 95 Degree is intended for temporary fixation, correction or stabilization of bones in the proximal and/or distal femur.

Condylar Plate 95 Degree

Condylar Plate 95 Degree Specification

Plates are made of 316L stainless steel and Titanium.
The Condylar Plate is available in 50 mm, 60 mm, 70 mm and 80 mm blade length. Number of holes in plate are 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 18 holes.
The angle between blade and shaft is 95 Degree in Plate.
Two first holes in plates next to blade used for 6.5 mm Cancellous Screw and rest holes in plates used for 4.5 mm Cortical Screws.
6.5 mm Cancellous Screws available thread lengths are 16 mm thread, 32 mm thread and Fully threaded. Screws are available in a wide range of length with 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115 and 120. Any extra Screws length will be made on order.
4.5 mm Cortical Screws are available in a wide range of length with 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 55, 60, 65, 70, 75, 80, 85 and 90mm. Any extra Screws length will be made on order.
The number of screw holes per plate length is maximized, without compromising plate strength. This allows an increased number of fixation points with a smaller incision.
General Instruments are available for Condylar Plate such as Plate Bending Press, Plate Holding Forceps, Plate Bending Pliers, Bone Holding Forceps, Bone Elevators, Bone Cutter, Bone Nibbler, Depth Gauge, Sleeve, Screw Driver, Trocar Sleeve etc.

Condylar Plate 95 Degree Uses

Condylar Plate is indicated for the fractures and revisions of the proximal and distal third of the femur in skeletally mature patients.

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Condylar Plate 95 Degree Surgical Technique

Insert guide wires

Fix condylar fragments with 6.5 mm cancellous lag screws, avoiding the planned insertion site of the blade. Bend the knee to 90° and mark the joint axis with the first Kirschner wire. Insert the second K-wire anteriorly over the patellofemoral surface of the condyles to mark the inclination. Mark the entry slot for the plate. Insert a third K-wire distal to the slot. This third wire must be parallel to the first wire in the AP view and to the second wire in the axial view. Check position with C-arm. Remove wires. The third wire indicates the direction of insertion of the seating chisel. Check the position with the condylar plate guide.

Insert chisel

In dense bone, predrill the channel with a 4.5 mm drill bit. Bevel the proximal rim with the chisel to avoid shattering of the cortex and to improve seating of the plate. Set the chisel guide at 85°, to result in 95° placement of the plate. Hammer the seating chisel in parallel to the K-wire in both planes. Check that the flap of the chisel guide is in line with the femoral shaft axis. Control rotation with the slotted hammer. After reaching the desired depth, take off the chisel guide and remove the seating chisel with the slotted hammer.

Insert plate

Fix the selected plate in the inserter -extractor, ensuring the blade is horizontally aligned with the handle, and tighten the bolt with the open-end wrench. Push the plate into the prepared channel and insert with light hammer blows. Control rotation with the slotted hammer. Remove the inserter-extractor, and use the impactor for final seating of the plate.

Secure plate to distal fragment

Predrill with a 3.2 mm drill bit through the round hole nearest the blade. In dense bone, the near cortex may have to be drilled with a 4.5 mm drill bit, to accept the screwshaft without cracking. Insert the appropriate length 6.5 mm partially threaded cancellous bone screw (to seat the plate and secure the medial fragment). Repeat the steps to insert a second 6.5 mm screw through the second round plate hole.

Secure plate to shaft

Fix the plate shaft to the bone with a 4.5 mm cortex screw.
Note: If axial compression is desired, first use the articulated tension device (ATD). Hook the opened device into the most proximal plate hole and fix to the bone with a short cortex screw. Tighten the bolt of the device to obtain the necessary compression. Insert additional 4.5 mm screws. Remove the ATD to insert the last two 4.5 mm cortex screws. Perform final tightening of screws.

Condylar Plate 95 Degree Contraindications

Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

Any active or suspected latent infection or marked local inflammation in or about the affected area.
Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.
Material sensitivity, documented or suspected.
Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to
failure of the device itself.
Patients having inadequate tissue coverage over the operative site.
Implant utilization that would interfere with anatomical structures or physiological performance.
Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
Other medical or surgical conditions which would preclude the potential benefit of surgery.
All associated diseases which could endanger the function and success of the Condylar Plate 95 Degree.

Warnings and Precautionary for Condylar Plate 95 Degree

Before using Condylar Plate 95 Degree, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.

Condylar Plate 95 Degree is made from medical grade materials and are designed, constructed and produced with utmost care. These quality plate assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.

Improper use of Condylar Plate 95 Degree can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.

It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of this plate.

Factors which could impair the success of the operation:

Allergies to implanted materials.
Localized bone tumours.
Osteoporosis or osteomalacia.
System disease and metabolic disturbances.
Alcohol and drug abuse.
Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
Patients who are mentally unable to understand and comply with the doctor’s instructions.
Poor general health.

Possible Adverse Effects

The following adverse effects are the most common resulting from implantation:

Loosening of the implant, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
Early and late infection.
Further bone fracture resulting from unusual stress or weakened bone substance.
Temporary or chronic neural damage resulting from pressure or hematomata.
Wound hematomas and delayed wound healing.
Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
Heterotopic ossification.
Pain and discomfort due to presence of the implant.
Mechanical failure of the implant, including bending, loosening or breakage.
Migration of implant resulting in injury.

Preoperative Planning for Condylar Plate 95 Degree

The operating planning is carried out following a thorough clinical evaluation of the patient, Also, x-rays must be taken to allow a clear indication of the bony anatomy and associated deformities. At the time of the operation, the corresponding implantation instruments in addition to a complete set of Condylar Plate 95 Degree must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of this plate. It is important to determine pre-operatively whether the patient is allergic to any of the implant materials. Also, the patient needs to be informed that the performance of the device cannot be guaranteed as complications can affect the life expectancy of the device.

Condylar Plate 95 Degree Precautions

Confirm functionality of instruments and check for wear during reprocessing. Replace worn or damaged instruments prior to use.
It is recommended to use the instruments identified for this screw.
Handle devices with care and dispose worn bone cutting instruments in a sharps container.
Always irrigate and apply suction for removal of debris potentially generated during implantation or removal.

Condylar Plate 95 Degree Warnings

Condylar Plate 95 Degree can break during use (when subjected to excessive forces). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail.
Instruments, screws and cut plates may have sharp edges or moving joints that may pinch or tear user’s glove or skin.
Take care to remove all fragments that are not fixated during the surgery.
While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Implant removal should be followed by adequate post-operative management to avoid refracture.

Condylar Plate 95 Degree General Adverse Events

As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the implant, reoperation.

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