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Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The surgeon in controlling leg length and offset discrepancies. The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.

The Lantern® Hip (modified device) utilizes a palm- sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies The Lantern® Hip consists of the sterile, single-use Lantern® Hip navigation unit (packaging includes reference sensor, CR2 battery and femur sensor battery), the non-sterile reusable reference sensor, the non-sterile reusable femur sensor, and associated non-sterile reusable instrumentation. The Lantern® Hip unit is sterile unless the sterile packaging is opened or damaged.

The OrthAlign Plus® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection The OrthAlign HipAlign® Sterile Pin Pack is indicated for use with the OrthAlign Plus® System. Intended Use: The OrthAlign® HipAlign® Sterile Pin Pack is intended to be used with the OrthAlign Plus® system specific to Total Hip Arthroplasty.

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display anqular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes, The OrthAlign HipAliqn® Sterile Pin Pack is a set of sterile, single use pins used in conjunction with the OrthAlign Plus® system of instruments and electronics. The OrthAlign® HipAlign® Pin Pack includes: - . Pelvic Fixation pins: 4.0mm in diameter and 90mm to 140mm in length - Pelvic Fixation pins: 5mm in diameter and 170mm in length - . Femoral registration markers: 4.0mm to 4.5mm in diameter and 16mm to 25mm in length

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - Total Hip Arthroplasty: Anterior/Posterior - Unicompartmental Knee Arthroplasty: Tibial transverse resection - Ligament Balancing

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Unicompartmental Knee Arthroplasty Tibial Transverse Resection

The KneeAlign® 2 System is a non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® 2 System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In total knee arthroplasty procedures, the device assists the surgeon in: - . Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia. In unicompartmental knee arthroplasty procedures, the device assists the surgeon in: - Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

The OrthAlign Plus System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - Total Hip Arthroplasty: Anterior/Posterior The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty The HipAlign® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - Total Hip Arthroplasty: Anterior / Posterior

The OrthAlign Plus® System is an innovative non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation. The OrthAlign Plus® System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus® System includes the singleuse OrthAlign Plus® Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus® Unit and only one of the Instrument Sets. The OrthAlign Plus System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus® System.

The OrthAlign Plus™ System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus" System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty o - Total Hip Arthroplasty: Anterior / Posterior . The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrument and structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty The HipAlign System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - · Total Hip Arthroplasty: Anterior / Posterior

The OrthAlign Plus" System is an innovative non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus" " System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus" System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In knee arthroplasty procedures, the device assists the surgeon in: - Establishing the mechanical axis of the femur, determining the varus/valgus angle . and the flexion/extension angle of the cutting block relative to femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus angle . and the posterior slope angle of the cutting block relative to tibia. In hip arthroplasty procedures, the device assists the surgeon in: - Establishing the orientation of the anterior pelvic plane and determining the . inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane. The OrthAlign Plus™ System comprises a single use computer module and reusable instrumentation. The OrthAlign Plus™ System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus" System includes the singleuse OrthAlign Plus™ Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus" Unit and only one of the Instrument Sets. Indications for Use for each optional configuration are limited to the applicable orthopedic procedure. The OrthAlign Plus" System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus™ System.

The KneeAlign® 2 System is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty

The KneeAlign® 2 System is an innovative non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® System is configured to detect, measure, and display angular measurement changes in a triaxial format. The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In knee arthroplasty procedures, the device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia. The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.