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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758). Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

- 1. Loss of joint configuration and joint function. - 2. Osteoarthritis of the knee joint. - 3. Rheumatoid arthritis of the knee joint. - 4. Post-traumatic arthritis of the knee joint. - 5. Valgus, varus, or flexion deformities of the knee joint. - 6. Revision procedures where other treatments or devices have failed. The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures. The BKS is indicated in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability. BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications requirements. The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions. The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications. The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offiset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569). The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method. Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.

This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: - Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. - Previously failed hip surgery. - Fractures of the femoral neck or head. - Avascular necrosis of the femoral head. - Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone. The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs. The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.

This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of the femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The Ibis™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, noncervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (TI - S1/Illium) for the following indications: 1) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2) Degenerative Spondylolisthesis with objective evidence of neurologic impairment 3) Trauma (fracture or dislocation) 4) Spinal tumor 5) Failed previous fusion (pseudarthrosis) 6) Spinal stenosis 7) Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Ibis™ Pedicle Screw System consists of bulleted rods; cannulated polyaxial, and extended tab screws; and set screws; which can be variously assembled to provide immobilization of the thoracolumbar and lumbosacral spine. The Ibis™ Pedicle Screw System maintains compatibility with the Pagoda™ Pedicle Screw System. All components are made from Titanium Alloy (Ti6Al4V).

The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants. The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of: 1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis 2. Previously failed surgery 3. Proximal femoral neck fractures or dislocation 4. Idiopathic avascular necrosis of the femoral head 5. Non-union of proximal femoral neck fractures 6. Treatment of fractures that are unmanageable using other forms of therapy 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.

The Ovation Tribute and Ovation Narrow Hip Stems are intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants. Indications for Use: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications: 1. Active sepsis which requires a two-stage revision arthroplasty procedure 2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period 3. Implantation period of 180 days or less Use only with polymethylmethacrylate/gentamicin bone cement. The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

The Ovation 10/12 Hip Stem is intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants. The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of: 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Proximal femoral neck fractures or dislocation. 4. Idiopathic avascular necrosis of femoral head. 5. Non-union of proximal femoral neck fractures. 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The Ovation 10/12 Hip Stem is a one-piece press-fit tapered femoral stem, designed for single, uncemented use. The system consists of a variety of sizes to accommodate the majority of patients encountered, lengths (98-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°. The Ovation 10/12 Hip Stem has a rectangular cross-section and provides stability through a 3point fixation. The femoral stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6Al-4V ELI). The proximal portion of the stem is plasma-sprayed with titanium alloy (ASTM F-1580).

The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications: 1. Loss of knee joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.