# K240043: EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse - Pathway: 510(k) (Traditional) - Applicant: Microport Orthopedics, Inc. - Decided: Apr 1, 2024 after 87 days - Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer) - Device class: 2 - Regulation: 21 CFR 888.3510 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K033890 (2004). 37 ancestors in all. No later device cites it as a predicate yet. 1 of 38 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K230563: EVOLUTION® Hinge Knee System, Microport Orthopedics, Inc. (2023) Summary page 25. - K013035: Guardian Limb Salvage System, Wrightmedicaltechnologyinc (2001) Summary page 25. - K910596: DCW Modular Distal Femoral System, Dow Corning Wright (1991) Summary page 25. - K021489: Repiphysis Limb Salvage System, Wrightmedicaltechnologyinc (2002) Summary page 25. - K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts, Microport Orthopedics, Inc. (2014) Summary page 32. - K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 32. - K102380: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2011) Summary page 32. - K113325: Evolution MP Adaptive CS Insert, Wrightmedicaltechnologyinc (2011) Summary page 32. - K131679: Evolution MP Adaptive PS Tibial Insert, Wrightmedicaltechnologyinc (2013) Summary page 32. - K171389: EVOLUTION Revision CCK System, Microport Orthopedics, Inc. (2017) Summary page 32. - K033890: Advance Double High Insert, Wrightmedicaltechnologyinc (2004) Summary page 32. - K081479: Advance a-Class Tibial Insert, Wrightmedicaltechnologyinc (2009) Summary page 32. - K972626: Advance Knee System, Wrightmedicaltechnologyinc (1997) Summary page 32. - K972770: Advance Ultra-Congruent Tibial Insert, Wrightmedicaltechnologyinc (1997) Summary page 32. - K990030: Advanced Revision Product Line Extension, Wrightmedicaltechnologyinc (1999) Summary page 32. - K122218: Advance Total Knee System-Patella, Wrightmedicaltechnologyinc (2013) Summary page 32. - K960617: Advance Tibial Component, Wrightmedicaltechnologyinc (1996) Summary page 32. - K861715: Whiteside Condylar II Total Knee Prosthesis, Dow Corning Wright (1986) Summary page 32. - K864070: Whiteside Ortholoc (TM), Dow Corning Wright (1987) Summary page 32. - K893252: Whiteside Ortholoc M.a. Total Knee System, Dow Corning Wright (1989) Summary page 32. - K926334: Axiom Total Knee Syst/Acl Retain Tibial Tray/Inser, Orthomet, Inc. (1994) Summary page 32. - K912894: Axiom Total Knee System, a/P Curved Tibial Insert, Orthomet, Inc. (1991) Summary page 32. - K894334: Second Generation Knee System, Orthomet, Inc. (1989) Summary page 32. - K901992: Whiteside Ortholoc Modular Post. Stab. Knee System, Dow Corning Wright (1990) Summary page 32. - K932677: Axiom Total Knee System, Orthomet, Inc. (1994) Summary page 32. - K933289: Thick Tibial Insert, Wrightmedicaltechnologyinc (1994) Summary page 32. - K935080: Insall-Burstein II, Hospital For Special Surgery (1995) Summary page 33. - K940235: Ortholoc Advantim PS Lsi Tibial Insert, Wrightmedicaltechnologyinc (1994) Summary page 33. - K953439: Ultrack Total Knee System, Wrightmedicaltechnologyinc (1996) Summary page 33. ## Indications for use The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Hinge Knee System implants are for cemented use only. GUARDIAN™ Limb Salvage Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions: 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) The GUARDIAN™ Limb Salvage Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) The DCW Modular Distal Femoral System is primarily indicated for procedures in which a variable resection length prosthesis is necessary to accommodate the condition of the femur, e.g. bone loss/removal in disease-related knee arthroplasty or a distally fractured femur. It is also indicated for revision of a previous total knee replacement where the femoral prosthesis has loosened, broken, or requires surgical removal for another medical reason. These indications are intended to provide relief of pain and restoration of knee function in skeletally mature patients. Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions: 1. patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications. 3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) The EVOLUTION® MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Total Knee System nonporous components are for cemented use only. The EVOLUTION® Total Knee System porous components are for use without bone cement. The ADVANCE® Total Knee System components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Total Knee System is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement. The Whiteside Condylar II™ Total Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis or inflammatory arthritis or traumatic arthritis, with or without moderate valgus, varus, or flexion deformities. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only. The Whiteside ORTHOLOC™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. The prosthesis is also indicated for revision of a failed prosthesis where the cruciate ligaments are absent but the collateral ligaments are intact. The device is intended for cemented use only. The Whiteside ORTHOLOC® M.A. Total Knee System is indicated for use in conjunction with the metal tibial base of the Whiteside ORTHOLOC® II Total Knee System for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental or tricompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only. The AXIOM ACL Retaining Tibial Tray and Tibial Insert are used in total knee arthroplasty for replacement of the tibial plateau of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. AXIOM ACL Retaining Tibial Tray and Tibial Insert are for cemented use only. The A/P Curved Tibial Insert is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The A/P Curved Tibial Insert is intended for cemented application only. The Second Generation Knee System is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The Second Generation Knee System is intended for cemented application only. The Whiteside ORTHOLOC® Modular Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bi compartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis, where the cruciate ligaments are absent. This device is intended for cemented use only. The Modular Femoral Component and Constrained Tibial insert are used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. Additional indications specific to the Modular Femoral Component and Constrained Tibial Insert include use in patients with anterior/posterior, varus/valgus, and rotational joint instability resulting from inadequate or absent cruciate and collateral ligaments, or who's knee can not be stabilized by usual soft tissue management. This device is intended for single use in a cemented application only. The ORTHOLOC® Tibial Plastic Insert, as part the ORTHOLOC® Total Knee System, is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The system is also indicated for revision of failed prosthesis where the posterior cruciate and collateral ligaments are intact. This device is intended for cemented use only. Total knee arthroplasty has been proved effective in reducing or relieving pain and in restoring functional knee motion. Such surgical procedures have been used in the management of: painful disabling bicompartmentaljoint disease secondary to· osteoarthritis, rheumatoid, or traumatic arthritis; posttraumatic loss ofjoint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. The device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cemented use only. The ORTHOLOC® ADVANTIM™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental or tricompartmentaljoint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis, where the cruciate ligaments are absent. The ULTRACK™ Total Knee System is intended for bicompartmental or tricompartmental replacement of the knee joint for reduction of pain or increased function for the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. This device is intended for cemented use only. Source page: https://510kreport.com/device/K240043 Methodology: https://510kreport.com/methodology