(29 days)
The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. 2. - Acute traumatic facture of the femoral head or 3. neck. - Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Certain cases of ankylosis. 5.
The DePuy C-Stem System hip stem is a collarless, triple-tapered polished stem slim-profiled, manufactured from stainless steel. The C-Stem system also includes an end cap made from either gelatin or PMMA and PMMA centralizers.
The provided text is a 510(k) summary for the DePuy C-Stem™ System, a total hip joint replacement prosthesis. It does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, etc.).
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (K982918 DePuy C-Stem System), rather than providing detailed performance studies against specific acceptance criteria.
The key points from the provided text are:
- Device: DePuy C-Stem™ System
- Classification: Class II Device (21 CFR 888.3350)
- Intended Use: Total hip arthroplasty to increase patient mobility and reduce pain.
- Indications for Use: Severely painful/disabled joint from various conditions (osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia), avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis.
- Substantial Equivalence Claim: The document states that "The fundamental scientific technology of the C-Stem System has not changed from the FDA cleared DePuy C-Stem System described in K982918. The intended use and indications for use have not changed. The material from which the additional end cap is manufactured has been changed to PMMA, the same material used to manufacture other legally marketed end cap devices."
- Approval Basis: Conformance with design control procedures and similarities in design, intended use, and indications for use to the predicate device.
Therefore, I cannot fill out the requested table or answer most of the questions because the provided text does not contain the necessary information regarding acceptance criteria or a performance study.
The document is a regulatory filing focused on demonstrating equivalence for market clearance, not on providing a study with specific performance metrics against pre-defined acceptance criteria for a new or significantly modified device requiring such studies.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.