Profile: ConforMIS offers patient-specific implants and instrumentation devices. Our disposables, patient-specific cutting and placement guides eliminates many of the tools required for traditional orthopedic surgical technique. ConforMIS transforms traditional CT and MR data into patient-specific implants and instrumentation employing two image-to-implant technology platforms. Our iFitT technology converts CT and MR data into implants that are sized and shaped to conform to the 3D topography of an individual joint. Our iJigT instrumentation eliminates the need for manual sizing, surgical time, trauma and improves reproducibility. Our product line includes iFormaT, iUniT, iDuoT & iTotalT. Our iDuo bicompartmental resurfacing device is an FDA cleared implant designed for the treatment of osteoarthritis.
The company was founded in 2004.
FDA Registration Number: 3004153240
7 Products/Services (Click for related suppliers)
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| • Forceps (FDA Code: HTD / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (FDA Code: HSX / 888.3520) A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (888.3027). |
| • Orthopedic Implant Devices |
| • Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
| • Polymer/Metal/Polymer Cemented Semi-Constrained Partial Knee Patellofemorotibial Prosthesis (FDA Code: NPJ / 888.3560) A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027). |
| • Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560) |
| • Tibial (hemi-knee) Metallic Resurfacing Uncemented Prosthesis (FDA Code: HSH / 888.3590) A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (888.3027). |