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3S HEMI IMPLANT SYSTEM

3S HEMI IMPLANT SYSTEM

3S HEMI IMPLANT SYSTEM

Product catalog summary
Overview of the 3S Hemi Toe Implant System
The 3S Hemi Implant System is designed to replace the articulating surface of the proximal phalanx of the first metatarsophalangeal joint. It includes a cobalt chromium implant and necessary instrumentation for insertion. Key features include a radiused, low-profile anatomical head shape for natural articulation, a tri-spade stem design for stability and optimal osteointegration, and a sharp chisel-tip stem for easy placement.
Surgical Procedure
  • Step 1: Make a 4cm to 5cm dorsal incision to expose the joint capsule.
  • Step 2: Retract tissues and incise the capsule for joint exposure.
  • Step 3: Resect the articular surface of the phalanx with a saw, ensuring proper implant head thickness.
  • Step 4: Remove osteophytes to allow normal motion.
  • Step 5: Determine implant size using sizers.
  • Step 6: Create a guide hole with an awl and mallet.
  • Step 7: Insert a trial implant and check for tension and motion.
  • Step 8: Optional broaching for dense bone.
  • Step 9: Place the implant using an impactor.
  • Step 10: Check alignment and range of motion.
  • Step 11: Irrigate, remove debris, and close the incision.
Implant Specifications
The system includes implants of various sizes (Small, Medium, Large, X-Large) with specific dimensions for height, width, and depth. All necessary instruments are included in the system.
Regulatory and Manufacturer Information
The 3S Hemi Implant System is FDA cleared under 510(k) K072922 and manufactured by DJO, LLC in the USA. The document emphasizes that individual results may vary and that only qualified surgeons can determine appropriate treatments. It also includes a disclaimer about the non-medical nature of the document's content.
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Catalog excerpts

3S HEMI IMPLANT SYSTEM-1

3S HEMI TOE IMPLANT SYSTEM The 3S Hemi Implant System consists of a cobalt chromium (CoCrMo) implant to replace the articulating surface of the proximal phalanx of the first metatarsophalangeal joint and corresponding instrumentation to facilitate insertion. • Radiused, low profile anatomical head shape to allow for natural articulation and to provide the option of preserving host bone • Tri-spade stem design intended to maximize stability and bone-to-implant contact for optimal osteointegration • Sharp chisel-tip stem for simple initiation and placement • Simple surgical technique for reduced OR

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3S HEMI IMPLANT SYSTEM-2

3S HEMI IMPLANT SYSTEM SURGICAL TECHNIQUE STEP 1: Expose the 1st metatarsal phalangeal joint with a 4cm to 5cm slightly curved dorsal incision just medial to the EHL tendon, allowing proper dissection to expose the joint capsule. STEP 2: Retract the tissues, then incise the capsule with a “T” incision at the MPJ for exposure of the phalangeal base and the metatarsal head. Carefully release the capsular structures from the medial, dorsal, and anteriolateral aspects of the joint. STEP 3: Resect the articular surface of phalanx with an oscillating or sagittal saw, making the cut perpendicular to...

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