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EXULT Knee Replacement System is indicated for the treatment of diseases as follows: - Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; - Post-traumatic loss of knee joint configuration and function; - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The EXULT Knee Replacement System is intended for cemented use only.

The purpose of this submission is to introduce EXULT Tibial Insert UCR (Ultra Congruent & Cruciate Retaining) which is a line extension to the EXULT Knee Replacement System. The EXULT Tibial Insert UCR is a modification to the PCL (Posterior Cruciate Ligament) notch of the EXULT Tibial Insert UC (K242046). This change allows the EXULT Tibial Insert UC to be used by surgeons who do not resect the PCL when implanting an EXULT Tibial Insert UC. Tibial Insert is used at both right and left knee. It is only used in combination with the same Femoral component and Tibial baseplate of the predicate device.

EXULT Knee Replacement System is intended for the treatment of diseases as follows: - Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis. - Post-traumatic loss of knee joint configuration and function. - . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - . Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure EXULT Knee Replacement System is intended for cemented application only.

The purpose of the submission is a line extension of the EXULT Tibial Insert (CPS-type) to the EXULT Knee Replacement System (K192507). The CPS-type Tibial Inserts are designed based on the design of the other previously cleared Tibial Inserts of the EXULT Knee Replacement System (PS-type, CR-type and UC-type). The CPS-type, which is constrained posterior stabilized, has a thicker and wider post which provides additional constraint as compared to the PS-type insert. The CPS-type Tibial Insert matches with Femoral Components of one-size up and down. The CPS-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

EXULT Knee Replacement System is indicated for the treatment of diseases as follows: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis traumatic arthritis or avascular necrosis) or rheumatoid arthritis. · Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. EXULT Knee Replacement System is intended for cemented application only.

The purpose of the submission is a line extension of the EXULT Tibial Insert (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

BENCOX Delta Option Heads of BENCOX Total Hip System is intended for Cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis b. Inflammatory degenerative joint disease, such as rheumatoid arthritis c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty

The BENCOX Delta Option Head consists of a delta ball head and a titanium sleeve (Ti6Al4V). The ball heads are made of the BIOLOX® delta ceramic material, which is a high-purity alumina composite material according to ISO 6474-2 Type X, and come in various outer diameters. The ceramic BIOLOX® delta ball head is assembled with the corresponding titanium sleeve and is then placed over the titanium alloy tapers of an in-situ hip stem prosthesis. The titanium sleeve has an inner taper which fits the dimensions of a metallic hip stem prosthesis, and the BIOLOX® delta ball head has a taper which fits to the dimensions of the outer diameter of the titanium sleeve.

BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for Cementless use in total hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis b. Inflammatory degenerative joint disease, such as rheumatoid arthritis c. Treatment of non-union, femoral neck fracture, and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty

The subject BENCOX Mirabo Z cup Cortinium shares key design features, materials, Indications for Use statements, geometry, and compatibility with other Corentec acetabular components marketed under the brand names BENCOX Mirabo Cup System and BENCOX Mirabo Z Cup Cortinium. The BENCOX Mirabo Z cup Cortinium is similar to the predicate devices BENCOX Mirabo Z Cup Cortinium cleared under K210614 and Bencox Mirabo Cups cleared under K220468, K172806, K162127, K120924 with respect to material - Titanium alloy (ASTM F136), and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process, design, locking system, manufacturing (without coating processes), packaging and sterilization. This submission is only for the inclusion of specification of BENCOX Mirabo Z Cup Cortinium with external diameter 50mm. The manufacturing process including additive manufacturing is identical to the predicate. The subject 50mm acetabular shell is thinner than the predicate 50mm shells but it is not thinner than other sized shells in the predicate submission. Otherwise, the geometry of the features is identical to the predicate. The subject devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation to legally marketed device cleared under K120924, K162127, K172806, K220468 and K210614.

LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; · Post-traumatic loss of knee joint configuration and function; • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability: · Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. LOSPA TKR System is intended for cemented application only. EXULT Knee System is intended for the treatment of diseases as follows: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; · Post-traumatic loss of knee joint configuration and function; • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability: · Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. EXULT Knee System is intended for cemented application only.

The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures. LOSPA Modular Knee System Instruments: Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs. Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs. EXULT Knee System Instruments: AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.

LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; · Post-traumatic loss of knee joint configuration and function; · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; · Correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. LOSPA TRK System is intended for cemented application only.

The Additional components being added to the LOSPA TKR System are: Instrumentation (Tibial Insert Trial) - The subject LOSPA TKR System components specification inclusions are a line extension of Instrumentation (Tibial Insert trial). The following is the additional components. A) Instrumentation (Tibial Insert Trial) A copy of a final tibial prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee femoral component trial prosthesis and a tibial baseplate trial prosthesis. This instrument is a reusable device that must be sterilized prior to use. Additional Tibial Insert Trials are designed based on Tibial Insert Trials of predicate device cleared LOSPA TKR System Instrumentation under K110404 & K130673 & K160157 & K192507 & K200395. There is one eliminated size, 26T of each design (CR and PS), each for left and right sides. For both CR and PS designs, the ranges of dimensions are the same. The components have slightly modified height. Except for the differences of height, lengths are identical to the previously cleared Tibial insert trials. The subject LOSPA TKR System is available in nine proportional sizes. This Tibial Insert Trials are made of Propylux conforming to ASTM D4101: Standard Classification System and Basic for Specification for Polypropylene Injection and Extrusion Materials.

BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions: · non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis; · Inflammatory degenerative joint disease, such as rheumatoid arthritis; · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; · patients with failed previous surgery where pain, deformity, or dysfunction persists; · revision of previously failed total hip arthroplasty.

The Additional components being added to the BENCOX THR System are: - Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part) The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec. The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use. The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899: Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

EXULT Knee Replacement System is intended for the treatment of diseases as follows: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; · Post-traumatic loss of knee joint configuration and function; • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; · Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. EXULT Knee Replacement System is intended for cemented application only.

The Additional components being added to the EXULT Knee Replacement System are: - Instrumentation (Femoral Component Trial) - The subject EXULT Knee Replacement System components specification inclusions are a line extension of Instrumentation (Femoral Component trial). The following is the additional components. A) Instrumentation (Femoral Component Trial) A copy of a final femur prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material. This instrument is a reusable device that must be sterilized prior to use. Additional Femoral Component Trials are designed based on Femoral Component Trials of predicate device cleared EXULT Knee Replacement System Instrumentation under K200395. This femoral component trials are made of Stainless steel alloy conforming to ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments.

LOSPA II Knee System (EXULT Knee Replacement System) is indicated for the treatment of diseases as follows: · Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis; · Post-traumatic loss of knee joint configuration and function; · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; · Correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. LOSPA II Knee System (EXULT Knee Replacement System) is intended for cemented application only.

The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee Replacement System) are: - Revised Size 12 PS, CR Femoral Component - - Additional Size 13 PS, CR Femoral Component - - -Instrumentation The subject LOSPA II Knee System (EXULT Knee Replacement System) components specification inclusions are a line extension of Femoral Components and Instrumentation system.