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Gorilla Lapidus Arthrodesis System
The Gorilla® Lapidus Arthrodesis System development began around the concept of neutralization plating. A plate designed for the medial wall provides added stiffness since the plate is positioned on its side. Traditionally, medial wall plates add a complicating factor in that the distal screws apply adductory force on the first metatarsal as they are tightened to the plate. To combat this, Paragon 28® designed the plates to match the corrected metatarsal position as well as curvature, thus following the principles of a “bent plate technique” to limit the adductory force applied to the metatarsal. In addition, a medial wall plate is better positioned to prevent plantar gapping while avoiding the insertion of the tibialis anterior plantarly. The anatomic plate construct is designed to help reduce soft tissue irritation in an area where ample soft tissue coverage can be a concern with a poorly designed plate construct.
These features were incorporated into all 18 Lapidus arthrodesis plating options: standard, graft-spanning, and medial wall step-off.
A Precision® Guide Lapidus screw guide is provided in the system to allow for placement of a lag screw across the Lapidus arthrodesis while missing all other screws in the construct.
Paragon 28
Paragon 28
Paragon 28 manufactures products that address the under-served needs of the foot and ankle surgical community.
Standard Plates—Left and right side specific
- 1.3 mm thickness
- Compression slot present on all plates
Graft-Spanning Plate—Left and right side specific
- 1.6 mm thickness
- For use with Paragon 28® PRESERVE™ Grafts - Small Plate - 5 mm PRESERVE™ Lapidus Graft (offers compression slot) - Medium Plate - 8 mm and 10 mm PRESERVE™ Lapidus Graft - Large Plate - 12 mm and 14 mm PRESERVE™ Lapidus Graft
Medial Wall Step-Off Plates—Left and right side specific
- 1.4 mm thickness
- Size options include 1 mm step-off increments from 1-5 mm
- Compression slot present on all plates
Paragon 28®’s Design Rationale
Paragon 28® captured the essence of surgeon concerns with the Lapidus procedure by addressing them with several patented features: a medially positioned plate, a ramped plate proximally to avoid tendon irritation, anatomic curvature of the plate to provide a bent plate advantage, a plantar locking arm to better resist the tension side of the joint, and a Precision® Guide Lapidus for crossing screw insertion to avoid collision with the locking plate screws.
The bone plates and bone screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, distal fibula, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of the foot and ankle, including the tibia, fibula, tarsus, metatarsals, and phalanges, appropriate for the size of the device.
Use of the Baby Gorilla®/Gorilla® Plating System is contraindicated in cases of inflammation, cases of active or suspected sepsis/infection and osteomyelitis; or in patients with certain metabolic diseases. All applications that are not defined by the indications are contraindicated.
In addition, surgical success can be adversely affected by:
- Acute or chronic infections, local or systemic
- Vascular, muscular or neurological pathologies that compromise the concerned extremity
- All concomitant pathologies that could affect the function of the implant
- Osteopathies with reduced bone substance that could affect the function of the implant
- Any mental or neuromuscular disorder that could result in an unacceptable risk of failure at the time of fixation or complications in post-operative treatment
- Known or suspected sensitivity to metal
- Corpulence—an overweight patient can strain the implant to such a degree that stabilization or implant failure can occur
- Whenever the use of the implant comes into conflict with the anatomical structures of physiological status
Other medical or surgical pre-conditions that could compromise the potentially beneficial procedure, such as:
- The presence of tumors
- Congenital abnormalities
- Immunosuppressive pathologies
- Increased sedimentation rates that cannot be explained by other pathologies
- Increased leukocyte (WBC) count
- Pronounced left shift in the differential leukocyte count
- Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If corrective action is not taken, complications may occur.
- Use of an undersized plate or screw in areas of high functional stresses may lead to implant fracture and failure.
- Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site.
- The implants and guide wires are intended for single use only.
- Instruments, guide wires, and screws are to be treated as sharps.
- Patient risk as a result of the Baby Gorilla®/Gorilla® Plating System in the MR environment has been minimized.
- Do not implant the instruments.
In any surgical procedure, the potential for complications and adverse reactions exist. The risks and complications with these implants include:
- Loosening, deformation or fracture of the implant
- Acute postoperative wound infections and late infections with possible sepsis
- Migration, subluxation of the implant with resulting reduction in range of movement
- Fractures resulting from unilateral joint loading
- Thrombosis and embolism
- Wound hematoma and delayed wound healing
- Temporary and protracted functional neurological perturbation
- Tissue reactions as the result of allergy or foreign body reaction to dislodged particles
- Corrosion with localized tissue reaction and pain
- Pain, a feeling of malaise or abnormal sensations due to the implant used
- Bone loss due to stress shielding
All possible complications listed here are not typical of Paragon 28®, Inc. products but are in principle observed with any implant. Promptly inform Paragon 28®, Inc. as soon as complications occur in connection with the implants or surgical instruments used. In the event of premature failure of an implant in which a causal relationship with its geometry, surface quality or mechanical stability is suspected, please provide Paragon 28®, Inc. with the explant(s) in a cleaned, disinfected and sterile condition. Paragon 28®, Inc. cannot accept any other returns of used implants. The surgeon is held liable for complications associated with inadequate asepsis, inadequate preparation of the osseous implant bed in the case of implants, incorrect indication or surgical technique or incorrect patient information and consequent incorrect patient behavior.
