(87 days)
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 GUARDIANTM 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, 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 revious 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, 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 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 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 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 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, 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 intended for cemented use only.
Total knee arthroplasty has been proved effective in reducing pain and in restoring functional knee motion. Such surgical procedures have been used in the management of: painful disabling bicompartmental joint disease secondary to osteoarthritis, theumatic arthritis; posttraumatic loss of joint 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 joint disease secondary to osteoarthritis, inflammatory 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 replacement of the knee joint for reduction of pain or increased function for the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, 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.
The subject devices include the following affected components: Tibial spacers manufactured from UHMWPE; Tibial hinge base with stop pins manufactured from UHMWPE, titanium alloy, and cobalt chromium alloys; Hinge bushings manufactured from UHMWPE; Tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy, cobalt chromium tungsten allov, and cobalt chromium molybdenum alloy; Femoral axial pins manufactured from combination UHMWPE and cobalt chromium molybdenum alloy and combination high density polyethylene (HDPE) and cobalt chromium alloy; Yoke extension stops manufactured from UHMWPE; Patellae manufactured from UHMWPE and cobalt chromium tungsten alloy. The subject materials conform to the following standards: GUR 1050 UHMWPE conforming to ASTM F648; GUR 1020 UHMWPE conforming to ASTM F648; High-density polyethylene; Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy conforming to ASTM F136; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F75; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F799; GUR 1020 5 MRad Cross-linked Polyethylene conforming to ASTM F648; Cobalt-20Chromium-15Tungsten-10Nickel Alloy conforming to ASTM F90.
The provided text is a compilation of FDA 510(k) clearance letters and summaries for various knee and limb salvage systems manufactured by MicroPort Orthopedics Inc. These documents primarily address administrative changes related to sterilization suppliers and parameters and assert substantial equivalence to previously cleared devices.
Crucially, the documents explicitly state that "No bench testing, animal testing, or clinical testing was performed to support this submission" ([28]D, [37]D) and "Clinical data were not submitted or relied on for a determination of substantial equivalence" ([29]E, [37]E).
Therefore, based solely on the provided text, it's not possible to describe acceptance criteria or a study that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a newly designed medical device.
The "study" referenced in these documents is limited to:
- Validation of sterilization parameters (Ethylene Oxide Sterilization Validation Report) according to ISO standards (ISO 11135:2014, ISO/TS 21387, and ISO 10993-7:2008) to demonstrate the new supplier can achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility assessment of the materials, concluding no impact on biological safety due to the change in sterilization supplier/parameters.
The acceptance criteria here are related to the maintenance of sterility and biocompatibility following a change in the manufacturing process (specifically, the sterilization supplier and parameters) for devices that have already established substantial equivalence through previous 510(k) submissions.
Given this context, I will address the questions to the best of my ability based on the information provided, explicitly stating where information is "Not Applicable" or "Not Provided" due to the nature of this particular 510(k) submission (change in sterilization process for already cleared devices, not a new device performance study).
Acceptance Criteria and Study for Sterilization Process Change (based on the provided document)
The core "study" described in the provided text is the validation of a change in Ethylene Oxide (EO) sterilization supplier and parameters for a range of existing knee and limb salvage system implants. The device performance being "proven" here is the continued sterility and biocompatibility of these devices after this change, asserting they remain as safe and effective as their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Sterilization Process Change) | Reported Device Performance (from "Conclusion") |
|---|---|
| Sterility Assurance Level (SAL) of 10⁻⁶ Maintained | "The subject sterilization process underwent sterilization per standards ISO 11135:2014, ISO/TS 21387, and ISO 10993-7:2008 to demonstrate the new sterilization supplier can sterilize the subject devices to a Sterility Assurance level of 10⁻⁶. The sterilization shows that the new subject process is capable of achieving the same sterility performance compared to the predicate process." ([28]D, [37]D) |
| Biocompatibility Unaffected | "Furthermore, biocompatibility assessment of the subject materials determined material properties and device characteristics are unaffected by the subject modification." ([28]D, [37]D) |
| "The impact of the subject change on device materials and subsequent biocompatibility of finished devices was assessed, and it was determined that there was no impact to biological safety of implant materials." ([29]F, [37]F) | |
| Design, Safety, or Effectiveness Unchanged | "Validations concluded that the ethylene oxide sterilization change in supplier and parameters does not affect the design, safety, or effectiveness of the subject devices. The subject devices are as safe, as effective, and perform the same as the legally marketed predicate devices cited in this 510(k). The indications for use, intended patient population, design features, and fundamental scientific technology of the subject device are identical to the predicate devices." ([29]G, [38]G) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for the sterilization validation or biocompatibility assessment. It states that the "subject sterilization process underwent sterilization" and that "biocompatibility assessment... was assessed" ([28]D, [37]D). Regulatory requirements for sterilization validation (e.g., ISO 11135) dictate specific sample sizes for sterility testing (e.g., bioburden, sterility tests). However, these specific numbers are not provided in this summary.
- Data Provenance: The data comes from internal validation studies conducted by MicroPort Orthopedics Inc. (or their contracted sterilization supplier) to support the change. The country of origin for the data is not explicitly stated, but MicroPort Orthopedics Inc. is based in Arlington, Tennessee, USA ([24] Submitted by, [30] Submitted by). The studies are prospective in the sense that they were conducted specifically to validate the new sterilization process before seeking 510(k) clearance for the change.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable in this context. This 510(k) submission is about validating a manufacturing process change (sterilization), not evaluating clinical performance or diagnostic accuracy. Therefore, there is no "ground truth" established by clinical experts for a test set in the sense of image interpretation or medical diagnosis. The "ground truth" for sterilization is defined by established international standards (ISO series) for achieving a specific SAL, and for biocompatibility, by biological safety assessments.
4. Adjudication Method for the Test Set
- Not Applicable. As no clinical or diagnostic test set requiring expert interpretation or consensus was performed, no adjudication method was used. The assessment relied on adherence to scientific and engineering standards for sterilization and material biocompatibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. The device type (knee and limb salvage system implants) is a physical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The devices are physical implants, not algorithms.
7. The Type of Ground Truth Used
- The "ground truth" for this submission revolves around compliance with established international standards for sterilization and biocompatibility:
- Sterilization: The ground truth is the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ as defined by ISO 11135:2014 and ISO/TS 21387.
- Biocompatibility: The ground truth is the absence of adverse biological reactions as demonstrated by assessment against ISO 10993-7:2008 and other relevant biocompatibility standards, ensuring material properties and device characteristics are unaffected.
8. The Sample Size for the Training Set
- Not Applicable. This submission is not for a new device development involving a "training set" for an algorithm. The "training" in this context refers to manufacturing process validation.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set for an algorithm exists here. The "ground truth" for the overall device's safety and effectiveness was previously established by the predicate devices which had undergone their own respective regulatory clearances, covering aspects like design, materials, and clinical performance (if applicable). This 510(k) only addresses the impact of a change in sterilization supplier on these already established devices.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.