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The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee jount 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 This implant is intended for cemented use only. The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired. The iTotal Identity Posterior Stabilized 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: Pamful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, osteonerosis of the knee Post-traumatic loss of joint function Moderate varus, valgus, or 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 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 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 Identity™ Imprint™ PS 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, polyarthritis, osteonecrosis of the knee. Post-traumatic loss of joint function. Moderate varus, valgus, or 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 iTotal Identity and Identity Imprint Knee Replacement Systems (KRS) are semi-constrained total knee prosthetic devices consisting of femoral, tibial, and patellar components. These devices are intended for treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Patient imaging (CT scans) can be used to design patient-specific implants (iTotal Identity) or to select standard sized implants (Identity Imprint), to meet 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, patient-specific surgical instruments 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, 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. 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, traumatic arthritis, rheumatoid arthritis, 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 Conformis Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS hereafter referred as Identity Imprint KRS Knee Replacement System (KRS) represents a family of standardized Posterior Stabilized (PS) knee implants, Cruciate Retaining (CR) knee implants, and compatible system component product offerings based on the Identity Imprint PS and CR knee replacement systems. The total knee replacement system for each size includes a femoral implant, tibial tray, polyethylene inserts, patientspecific and standardized iligs, as well as surgical instrumentation. The system also includes an iView, generated utilizing Conformis' 'Best Fit' planning software. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. 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.

The iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) 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.

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a patient-specific tri-compartmental faceted knee replacement system. It is a posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. An optional Cruciate Sacrificing insert may be utilized when additional anterior-posterior constraint is desired. Using patient imaging (CT scans) and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts. The CS insert is a one-piece insert. The polyethylene inserts may be manufactured from either iPoly® (UHMWPE) or iPoly® XE (a Highly Cross-Linked, Vitamin-E Stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either iPoly® or iPoly® XE. For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal® Identity™ CR KRS 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 Cordera™ Hip System may be used with iligs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation. The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. The system can be used with or without a pre-operative CT scan that is used to design patient-specific instruments. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is 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 femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating 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 liner is provided with an impactor made of a biocompatible nylon material. The purpose of this submission is to add patient specific instruments (iJigs) and surgical plans (iViews) to the Cordera Hip System.

The iTotal Identity Posterior Stabilized 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 compartments, such as a 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 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.

Conformis knee replacement systems are patient-specific 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 patient-specific implant is designed 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, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity Posterior Stabilized Knee Replacement System 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 ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: · Joint impairment due to osteoarthritis or traumatic arthritis of the knee · Previous femoral condyle or tibial plateau fracture, creating loss of function · Valgus or varus deformity of the knee · 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 ConforMlS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solelyaddressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to: · Painful joint disease due to osteoarthritis · Traumatic arthritis of the knee Post traumatic loss of joint function · Failed osteotomies, hemiarthroplasties and unicondylar implants The Duo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions. The iDuo implant is intended for cemented use only. The iTotal Posterior Stabilized {PS) Knee Replacement System (KRS) 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, 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 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 iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: · Painful joint disease due to osteoarthritis, traumatic arthritis, theumatoid 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.

ConforMIS knee replacement systems are patient-specific 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 ortrauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.

The ConforMIS BeneFIT 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, traumatic arthritis, 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, manageable by other techniques. - Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is 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 femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating 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 fits through the acetabular shell screw holes and is 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 liner is provided with an impactor made of a biocompatible nylon material.

The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) 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, 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 iTotal Identity® Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal Identity CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal Identity CR KRS is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. Using patient imaging and a combination of proprietary and off the shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE), and either one or two polyethylene inserts. These inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked Vitamin E infused polyethylene). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE. For user convenience, and similar to the primary predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity CR KRS 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 iTotal Cruciate Retaining (CR) Knee Replacement System (KRS) 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 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 iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component. Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE. For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS 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 function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.