1. Catalogs
  2. Integra LifeSciences
  3. M.T.P. arthrodesis Hallu®-Fix system

M.T.P. arthrodesis Hallu®-Fix system

M.T.P. arthrodesis Hallu®-Fix system
1 / 12 PagesView full catalog

M.T.P. arthrodesis Hallu®-Fix system

Product catalog summary
Indications and Contraindications
The Hallu®-Fix system is designed for conditions like hallux rigidus, severe hallux valgus, deformities from rheumatoid arthritis, post-traumatic arthritis, and neuromuscular instability. The Hallu®-S plate is used for revising failed procedures. Contraindications include limited skin coverage, severe osteoporosis, and infection.
Surgical Technique
The procedure involves a dorsal longitudinal incision to access the metatarso-phalangeal joint. The Hallu®-Ream system is used to prepare joint surfaces, with bone resection to decompress the joint. Metatarsal and phalangeal preparations use K-wires and reamers for congruent surfaces for arthrodesis. The Hallu®-Fix plate is positioned and secured with screws.
Implant Specifications
Implants are non-sterile, single-use, and made from titanium alloy, intended for osteosynthesis of the first metatarso-phalangeal joint. The system includes various plates and screws, with warnings against bending the Hallu®-S plate.
Warnings and Precautions
Potential complications include pain, implant migration, and bone loss. Patients with severe osteoporosis, systemic disorders, or metal allergies require careful evaluation. Surgeons must ensure patients understand the risks and limitations.
Reprocessing Instructions
Products must be cleaned, decontaminated, and sterilized before use. Both manual and automatic cleaning methods are specified, with steam autoclaving preferred for sterilization. Implants are single-use and should not be reused.
Conclusion
The Hallu®-Fix system offers a comprehensive solution for MTP arthrodesis, focusing on accuracy, anatomical adaptation, and reproducibility. Proper surgical technique and patient selection are crucial for success.
Description of Medical Devices
Implants are non-sterile osteosynthesis screws made of titanium alloy, compliant with ISO 5832-3 and ASTM F136 standards.
Indications
Used for fixation in arthrodesis, osteotomies, or fractures in hand or foot surgery, including fixation of small bone fragments.
Contraindications
Not suitable for patients with acute or chronic inflammation, active infection, or metal allergies.
Warnings
Complications may arise in patients with poor physical condition, severe osteoporosis, or hypersensitivity to foreign materials.
Precautions for Use
Consider patient conditions such as addiction, infectious disease, malignancy, and psychological instability. Proper surgical techniques and patient management are crucial.
Instructions for Reprocessing
Products are sold non-sterile and must be cleaned, decontaminated, and sterilized before use. Manual and automatic cleaning methods are specified.
Use of the Implant
Use recommended instruments and inspect components preoperatively. Avoid modifying implants and ensure aseptic conditions.
Re-use of Implants
Implants should never be reused once implanted.
Re-sterilization
Allowed only for non-implanted products under specified conditions.
Preventative Actions for Patients
Avoid extreme positions, wear prescribed orthopedic shoes, and seek prompt medical attention for infections.
Storage
Store in a dry place.
Liability
Newdeal is not liable for any loss or damage arising from the use of the product. The device is restricted to sale by or on the order of a physician.
Instructions for Use
The HALLU®-FIX Arthrodesis Set is for single use and must be handled by qualified professionals. Instruments are for surgical use only and should not be implanted.
Sterilization Guidelines
The recommended sterilization method involves exposure at 134°C for 18 to 45 minutes. Alternative methods must be validated using appropriate laboratory techniques. EtO and cold sterilization are not recommended.
Instrument Examination
Instruments should be thoroughly examined for cracks, bending, or distortion before use. Instruments showing signs of wear or damage should not be used.
Safety Precautions
Safety glasses are advised when using active surgical instruments. Cannulated instruments require the appropriate K-wire, which must be renewed for each procedure. Instruments should not exceed the manufacturer's speed specifications (1500 revs/minute). Proper insertion and locking of instruments and accessories are crucial to avoid patient harm.
Surgeon's Responsibility
Surgeons are responsible for selecting appropriate techniques and instruments based on their training and experience. They must discuss potential risks and complications with patients prior to surgery.
Limitation of Liability
Newdeal is not liable for any loss or damage arising from the use of its products. The device is intended for use by trained orthopedic surgeons.
Product Information
For further information, contact the manufacturer or distributor. The document includes a catalog of various surgical instruments and their specifications, such as sizes, colors, and types of screws and plates.
See more

Catalog excerpts

M.T.P. arthrodesis Hallu®-Fix system-1

SURGICAL TECHNIQUE M.T.P. arthrodesis Hallu®-Fix system FOREFOOT SOLUTIONS™

 Open the catalog to page 1
M.T.P. arthrodesis Hallu®-Fix system-2

HALLU®-FIX The first COMPREHENSIVE system for MTP arthrodesis providing: Hallu®-C plate MTP arthrodesis plate Hallu®-S plate Revision of MTP arthrodesis plate Hallu®-Ream Phalangeal reamers Hallu® Snap-off Snap-off screw Hallu®-Ream Metatarsal reamers Hallux rigidus Severe hallux valgus (Im angle>20° &HV angle> 40°) Deformity from rheumatoid arthritis Post traumatic arthritis Neuromuscular instability Hallu®-S plate (only) : revision of Keller procedure, failed arthroplasty, failed fusion. CONTRAINDICATIONS • Limited skin coverage • Severe osteoporosis • Infection

 Open the catalog to page 2
M.T.P. arthrodesis Hallu®-Fix system-3

SURGICAL TECHNIQUE The foot is washed, prepped and draped in the normal sterile fashion. The surgery is done under tourniquet to avoid bleeding. I • INCISION A dorsal longitudinal incision is commonly used. This enables correct exposure of the metatarso-phalangeal joint. The incision is centered just medial to the extensor hallucis longus, and deepened to the joint capsule, through the subcutaneous tissues. The joint capsule is released and retractors are placed to expose the base of the proximal phalanx and metatarsal head. II • PREPARATION OF THE JOINT SURFACES WITH THE HALLU®-REAM SYSTEM The...

 Open the catalog to page 3
M.T.P. arthrodesis Hallu®-Fix system-4

Using the Quick coupling device (ref: 129 710ND) the Hallu®-ream reamer is then engaged over the 1.6 mm K-wire, and the metatarsal head is reamed. The 2 in 1 metatarsal reamer is bell shaped to allow barrel reaming and articular preparation in one step. The metatarsal metaphysis is reduced to a cylinder of constant diameter, while the metatarsal head surface is reamed to a convex cup-shaped surface. The metatarsal reamer is removed. The K-wire can be held to elevate the metatarsal head to enable the removal of the bone on the plantar aspect. Excess bone is removed with an osteotome or a rongeur....

 Open the catalog to page 4
M.T.P. arthrodesis Hallu®-Fix system-5

Care is taken not to penetrate the interphalangeal joint. Reaming must begin by using the smallest size of phalangeal reamer, size 14 mm; in order to avoid any excessive reaming. The metatarsal head should be protected when reaming. The reamer is placed on the 1.6 mm K-wire, and the surface of the phalanx is reamed, creating a concave cup-shaped surface. If necessary, due to the diameter of the articular surface of the phalanx, superior sizes of the phalangeal reamers can be used until the dimensions match the size used for the metatarsal reamer. When an additional bone graft is required, bone...

 Open the catalog to page 5
M.T.P. arthrodesis Hallu®-Fix system-6

The Hallu®-Fix plates both have a 10° lateral angulation (10° valgus) as well as a 10° dorsal flexion. The Hallu®-C plate can be bent by using 2 benders (ref: 129 731ND & 129 732ND), right & left, to match the degree of dorsal flexion required by the case or by the activity of the patient WARNING : • Do not bend the Hallu®-S plate. • The plates should not be bent and rebent again. Once the correct size and type of plate has been chosen, and adequate alignment achieved, a 1 mm K-wire is inserted through the central hole of the plate in the metatarsal head for temporary stabilization. The K-wire...

 Open the catalog to page 6
M.T.P. arthrodesis Hallu®-Fix system-7

The screw can be tightened down with the screwdriver from the Hallu®-Fix system. The oblong holes allow for angled and compressive screw fixation. The central K-wire can be removed when solid fixation of the plate is achieved. When all the screws have been inserted on the plate, they are tightened along the dorsal aspect of the plate. Note: a final additional screw can be directed across the plantar aspect of the joint. Closure is then performed in the normal and routine fashion. SURGICAL TECHNIQUE • HALLU®-FIX

 Open the catalog to page 7
M.T.P. arthrodesis Hallu®-Fix system-8

Hallu®-S plate Hallu®-C plate Hallu® Snap-off Depth gauge Cannulated screwdriver Plate bender left Plate bender right Drill diam. 1.9 mm Quick coupling

 Open the catalog to page 8
M.T.P. arthrodesis Hallu®-Fix system-9

NON-STERILE IMPLANTS FOR SURGERY • SINGLE USE In accordance with EEC directive 93/42 relative to medical devices, this product must be handled and/or implanted by WELL-TRAINED, QUALIFIED PERSONS, AWARE OF THESE DIRECTIONS FOR USE. 1 - Description of the medical devices: The implants - delivered non-sterile - are: - Osteosynthesis plates, existing in different models and sizes - They are made out of Titanium alloy within the frame of the standard ISO 5832-3 and ASTM F136 2 - Indications : Depending on the model, the osteosynthesis plates are indicated for use in fixation of: - Fractures, osteotomies...

 Open the catalog to page 9
M.T.P. arthrodesis Hallu®-Fix system-10

HALLU®-SNAP-OFF NON-STERILE IMPLANTS • SINGLE USE In accordance with EEC directive 93/42 relative to medical devices, this product must be handled and/or implanted by WELL-TRAINED, QUALIFIED PERSONS, AWARE OF THESE DIRECTIONS FOR USE. 1 - Description of the medical devices: The implants - delivered non-sterile - are: - osteosynthesis screws, existing in different models, diameters and lengths. They are made out of titanium alloy within the frame of the standard ISO 5832-3 and ASTM F136. 2 - Indications: They are indicated for use in: fixation of arthrodesis, osteotomies or fractures in hand or...

 Open the catalog to page 10
M.T.P. arthrodesis Hallu®-Fix system-11

SURGICAL INSTRUMENTS TO BE CONNECTED TO AN ACTIVE DEVICE In accordance with EEC directive 93/42 relative to medical devices, this product must be handled and/or implanted by WELLTRAINED, QUALIFIED PERSONS, AWARE OF THESE DIRECTIONS FOR USE. The following two methods have been validated by the manufacturer and can thus be used: Method: steam Cycle: wrapped gravity Temperature: 132°C Exposure time: 45 minutes Method: steam Cycle: wrapped gravity Temperature: 134°C Exposure time: 18 minutes These instruments are intended for use in surgery, and should be used only for the introduction of associated...

 Open the catalog to page 11
M.T.P. arthrodesis Hallu®-Fix system-12

HALLU®-C PLATE • Size 1 • 4 holes • green Size 2 5 holes yellow • Size 3 • 6 holes • blue HALLU® SNAP-OFF Catalog Number Description • Size 1 • 4 holes • green 40 mm • Size 2 5 holes yellow 45 mm • • Size 3 • 6 holes • blue • 50 mm • Left Left Left HALLU®-S PLATE Description Right Right Right Snap-off screw • length 12 mm Snap-off screw • length 14 mm Snap-off screw length 16 mm Snap-off screw • length 18 mm Snap-off screw length 20 mm Snap-off screw length 24 mm Snap-off screw « length 28 mm Snap-off screw • length 12 mm Snap-off screw • length 14 mm Snap-off screw length 16 mm Snap-off...

 Open the catalog to page 12

All Integra LifeSciences catalogs and technical brochures

  1. cadence

    4  Pages

  2. transducer

    2  Pages

  3. MAYFIELD®

    12  Pages

  4. SurgiMend®

    6  Pages

  5. DuraGen XS

    2  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.