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The Identity™ Imprint™ Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans The Ildentity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon. The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is proposed to be a modification from Identity™ Imprint™ Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316) to be compatible with the Identity™ Imprint™ Cruciate Sacrificing (CS) Tibial Insert cleared in K230844. This submission also seeks the inclusion of the cleared AIM2Surf software (K230846) for use with the subject device. This software is used by CAD to do preliminary surface planning. No software version change is required as the surface planning is unchanged between the predicate and subject devices. The Porous Ancillary Reusable instrument tray was modified and clearance of the modification is also sought. The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrficing (CS) Insert, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. It is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (CT scan), an Identity Imprint Porous implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CPTi) scaffold on the interior surface. The tibial tray is manufactured from a titanium alloy (Ti6Al4V-EL), with a CPTi porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6A4V-ELI) and CPTi porous metal backing. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary. The ldentity™ Imprint™ Porous Knee Replacement System is compatible with cemented Identity™ Imprint™ CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique. The subject CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately. The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment). The Cruciate Sacrificing tibial insert of iPoly™ XE is offered in thicknesses of 6mm to 18mm and is the same insert as cleared with Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with CS insert (K230844).

The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: - · Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. - · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. - · Revision procedures, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The subject device, Identity Imprint Porous Total Knee Replacement System (including Identity Imprint Porous Cruciate Retaining Total Knee Replacement System) is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with other Conformis Knee Replacement Systems (KRS), the Identity Imprint Porous Knee Replacement System (KRS) is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. The device is intended for cementless fixation however the surgeon may also use cement. Using patient imaging (CT scans), an Identity Imprint set of implants is selected. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CP Ti) scaffold on the interior surface. The tibial tray is manufactured from alloy (Ti6Al4V-ELI), with a CP Ti porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6Al4V-EL) and CPTi porous metal backing. The layer of CPTi scaffolding bonded to the femoral, tibial, and patellar implants provides a surface for porous ingrowth, promoting biological fixation and obviating the need for bone cement to achieve fixation. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately. The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment). The Imprint Porous Knee Replacement System is compatible with cemented Identity Imprint CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique.

The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the ACTERA™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to: - A severely painful and/or disabled joint from osteoarthrits, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia. - Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. - Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The ACTERA™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.

The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided. The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'. This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iligs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iligs and iViews are provided based on ordered options. The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.

The Identity Imprint CR Total Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. • Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans This implant is intended for cemented use only. The CS insert option should be utilized when additional anterior-posterior constraint is desired.

The subject device, Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. In addition, reusable orthopedic manual surgical instruments are provided separately. This submission also seeks clearance of Cruciate Sacrificing (CS) Insert to be used with the cleared (secondary predicate) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS).

Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to: · A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia. · Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. · Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.

The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484). The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580. The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.

Identity Imprint CR KRS The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee. - Post traumatic loss of joint function · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only. Identity Imprint PS KRS The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee. · Post traumatic loss of joint function - · Moderate varus, valgus or flexion deformity · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants · Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

Identity Imprint CR KRS The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee. - Post traumatic loss of joint function · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only. Identity Imprint PS KRS The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee. · Post traumatic loss of joint function - · Moderate varus, valgus or flexion deformity · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants · Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

The subject device. Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

Identity Imprint CR KRS The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only. Identity Imprint PS KRS The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee. · Post traumatic loss of joint function · Moderate varus, valgus or flexion deformity · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants · Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

The subject device. Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The Identity Imprint Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. - · Moderate varus, valgus of flexion deformity. - · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. - · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The Identity Imprint Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee. - · Post traumatic loss of joint function. - · Moderate varus, valgus of flexion deformity. - · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a new device offering of a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS). the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE. For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.