(47 days)
The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. Indications: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis 2. Correction of varus, valgus, or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasty 8. Trauma These device components are for cemented use only.
The Reduced Size Oncology Salvage System (OSS) offers a variety of component options for treatment in small adults and children that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. These device components are for cemented use only.
This document is a 510(k) premarket notification for the "Reduced Size Oncology Salvage System" by Biomet Orthopedics, Inc. It establishes substantial equivalence to a predicate device but does not contain information about the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval, not a performance study report.
Here's what I can extract/infer from the document regarding the device and its regulatory status:
- Device Name: Reduced Size Oncology Salvage System
- Applicant/Sponsor: Biomet Orthopedics, Inc.
- Legal Marketed Device to which Substantial Equivalence is Claimed (Predicate Device): Oncology Salvage System, K002757, Biomet, Inc.
- Indications for Use:
- Treatment in small adults and children requiring proximal femoral, distal femoral, total femur, or proximal tibial replacements.
- Resurfacing components for the proximal tibia and distal femur.
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus, or post-traumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total joint arthroplasty.
- Trauma.
- Usage: For cemented use only.
- Regulatory Classification: Class II device, Product Code: KRO, Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis (21 CFR 888.3510).
- Regulatory Action: FDA found the device substantially equivalent to a legally marketed predicate device.
Missing Information:
The provided text does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, nor data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size for human reader improvement.
- Standalone performance study (algorithm only without human-in-the-loop).
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as an FDA clearance letter based on substantial equivalence to an existing device, implying that the safety and effectiveness were demonstrated by comparison to the predicate, rather than through new, independent clinical performance studies detailed in this specific document. Such information would typically be in a separate clinical study report or a more detailed submission accessible during the 510(k) review process, but not typically summarized in the public-facing "Summary of Safety and Effectiveness" or the FDA clearance letter itself.
§ 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.