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The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.

The Crius PEEK Suture Anchor System is a soft-tissue to bone fixation device, provided preloaded on a disposable inserter. Crius PEEK Suture Anchor System includes four types Thread-Fix Anchor, Thread-Fix Ultra Anchor,Helicoil Anchor and Pile Anchor.The device is available in varying profile diameters. The system consists of a suture anchor, suture(except for Pile Anchor ), and insertion handle and insertion shaft) and is a sterile,single use device. The anchor body is manufactured from Polyetheretherketone(PEEK).The suture is made from ultra high molecular weight polyethylene(UHMWPE) available in white and blue/white colors. The blue dye used in the suture is Chromium-cobalt-aluminum oxide in accordance with 21 CFR 73.1015 regulations. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture. The insertion shaft is made from 304 stainless steel compliant with ISO 7153-1 and 630 stainless steel compliant with ISO 16061. The surgical instruments are provided non-sterile and shall be sterilized by the end user.

The Gemini Cervical Fusion Cage System is indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one levels from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Gemini Cervical Fusion Cage System requires additional supplemental fixation cleared for the cervical spine. The Gemini Cervical Fusion Cage System is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.

The Gemini Cervical Fusion Cage Systeme is an anterior cervical interbody device consisting of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is to be implanted via an open, anterior approach. The Gemini Cervical Fusion Cage System is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The radiolucent PEEK-OPTIMA®material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ISO13782 to permit verification of position. The Gemini Cervical Fusion Cage System is provided sterile via gamma irradiation for single use.Instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The Gemini Medical Cage System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Gemini Medical Cage System is manufactured from a biocompatible polymer (Polyetheretherketone (PEEK)) material embedded with radiopaque tantalum marker pins, which allow the surgeon to radiographically determine the position of the implant, both intraoperatively and postoperatively. The System consists of PEEK lumbar cages of various shape and size, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The top surface of the cages have anatomical design, parallel design and wedge-shaped design respectively to adapt various vertebrae anatomical scenarios. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages are sterile provided and for single use. There are six models to accommodate different types of superior and inferior end plates depending on their technical design and shape, LF-I, LF-II, LF-III, LF-IV, LF-V and LF-VI. LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II has flat top and bottom tooth surface, LF-III and LF-V have flat or wedge-shaped surface. LF-III, LF-IV and LF-V cages have a convex angle.