(35 days)
The Medial Rotation Knee™ System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for the reduction in relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis
• Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of varus, valgus, or post traumatic deformity
• Correction or revision of unsuccessful osteotomy or arthrodesis
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques
The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femoral component mating with a stemmed CoCr metal backed polyethylene Tibial and all-poly Patella components. The conguency in tibialfemoral and patellafemoral articulation allow for natural knee movement and ROM while minimizing polyethelene wear.
The provided text is a 510(k) summary for the Finsbury (Instruments) Limited Medial Rotation Knee. However, it does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria.
The 510(k) outlines:
- Device Name: Medial Rotation Knee™ System
- Intended Use: For single-use cemented implantation in total knee arthroplasty surgery for pain reduction/relief and/or improved knee function in skeletally mature patients with various conditions (osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis, deformities, revision procedures, unmanageable fractures).
- Basis of Substantial Equivalence: Claims substantial equivalence to existing semi-constrained metal/polyethylene total knee systems, specifically mentioning the FS 1000 Knee System, Advance Ultra-Congruent Tibial Insert, and Freeman/Samuelson Total Knee System.
- Summary of Safety and Effectiveness: States the device is "shown to be safe and effective with over 30 years of proven clinical use."
Missing Information:
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number of experts, adjudication methods for any test sets.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (beyond "proven clinical use" which is vague for specific performance metrics).
- Sample size for the training set or how ground truth was established for it.
The statement "shown to be safe and effective with over 30 years of proven clinical use" is the extent of the performance evidence provided in this summary. It relies on the predicate devices' long-standing use and the Medial Rotation Knee's similarity to them, rather than presenting new, specific performance study data for acceptance criteria. Without further supplementary documents, the detailed information requested cannot be extracted from the provided text.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.