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The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System is intended for cementless applications.

The Renovis Tesera Trabecular Technology (T3) Acetabular Shell System ("T" Acetabular Shell System") acetabular shells ("T" shells") are modifications of the Renovis A400 Surgical Hip Replacement System acetabular shells cleared through premarket notification K112897. This submission proposes the following design change: The proposed T shells will be manufactured from the same titanium alloy using an additive manufacturing process to fabricate the implant and porous structure concurrently, and have a thicker solid substrate and porous layer. The T shells are to be used with polyethylene liners, femoral components, acetabular shell trials, and other system specific instruments originally cleared in the Renovis A400 Surgical Hip System (K112897). The T shell is available in multiple configurations (no hole shell; cluster hole shell) and sizes (44 - 66 mm diameter). The liners attach to the shells under impaction with a snap lock mechanism.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations. The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.

The A200 Knee System is intended for use in total knee arthroplasty for the following indications: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended for cemented use only.

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments. The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5. Revision procedures where other treatment or devices have failed. The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

The Renovis Surgical Technologies, Inc. A400 Surgical Hip Replacement System (Renovis A400 Hip System) is a family of components designed in a variety of standard clinically usable sizes for cementless total hip replacements (i.e. replacements where both the femur and acetabulum are replaced). The system consists of four main components available in a variety of clinically usable sizes. A) Femoral Stem (titanium alloy) B) Femoral Head (CoCr and Biolox delta ceramic) C) Acetabular Cup (titanium alloy) D) Acetabular Liners (Mechanically annealed HXL polyethylene with and without alphatocopherol) The Renovis A400 Hip System implant components are provided sterile and are for single use.

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation). When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks. The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.

The Renovis Cannulated Screw System includes cannulated screws and washers, designed to provide secure fixation for various fracture, osteotomy and arthrodesis indications. All screws are cannulated for use over guide pins, allowing for accurate placement. Screws are available in a range of diameters and lengths in partially threaded designs. The system also includes washers to prevent the screw head from pulling through the cortex. The Renovis Cannulated Screw System implants are made from 316L stainless steel.

The Renovis T 710 Large External Fixation System is indicated for the following: - Stabilization/fixation of: - o Long bone fractures in tibia and femur - o Fractures of pelvis and ankle - Peri-articular and intra-articular fractures of knee and ankle o - . Joint arthrodesis - Non-unions and mal-unions . - Osteotomies

The Renovis T 710 Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins and clamp components are made from materials conforming to ASTM F136 and ASTM F138.

The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors. When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.