(87 days)
The DePuy aSphere M-Spec Head is indicated for use in the treatment of:
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head;
- Acute traumatic fracture of the femoral head or neck;
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis.
The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.
The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.
The provided text details a 510(k) premarket notification for the "DePuy aSphere M-Spec Head," a modular femoral head for total hip replacement. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document outlines:
- Device Description: The aSphere M-Spec Head is part of a modular prosthesis system for total hip replacement, mating with DePuy femoral stems and articulating with DePuy acetabular inserts and cups.
- Indications for Use: Treatment of severely painful/disabled joints due to various arthritic conditions, avascular necrosis, acute femoral head/neck fractures, failed previous surgeries, and certain cases of ankylosis.
- Intended Use: As part of the femoral component in total hip arthroplasty.
- Basis of Substantial Equivalence: Similarities in intended use, indications for use, materials, design, method of manufacture, sterilization, and packaging methods to previously cleared DePuy M-Spec Heads (K980513, internal documentation to K851422, and K060031).
The FDA's letter (K082585) confirms the device's substantial equivalence to predicate devices, allowing it to be marketed. This 510(k) pathway for medical device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with explicitly defined acceptance criteria for the new device's performance.
Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and a study proving their fulfillment, as this information is not present in the provided text. The document focuses on regulatory clearance based on equivalence, not on a detailed performance study with acceptance criteria.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.