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510(k) Data Aggregation
(266 days)
The b-ONE® Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia: treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection: and fracture-dislocation of the hip.
The b-ONE® Total Hip System KOSMO™ HA coated stems and Grit-Blasted stems are intended for cementless use only.
The b-ONE® Total Hip System KOSMO™ Stainless Steel stems are intended for cemented use only.
The b-ONE® Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
b-ONE® Total Hip System components are not intended for use with other total hip systems.
b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The b-ONE KOSMO Femoral Stems Sizes are offered in 12 femoral stem sizes ranging from size 0 to 10 with half size of 4.5 for Cementless Collared Standard, High, and Proportional Offset families and 11 femoral stem sizes ranging from size 1 to 10 with half size of 4.5 for Cementless Collarless/Collared Coxa Vara families and Cemented Standard and Proportional Offset families.
The subject stems are laser marked with the catalog number, company logo, size, and material. The KOSMO Femoral Stem is composed of titanium alloy Ti-6A1-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stems. The cementless stems are offered as either HA coated or Grit-blasted.
The b-ONE Cement Restrictor is made from UHMWPE (ASTM F648/ISO 5834-1). The restrictor is offered in 7 different sizes with a major diameter of 9, 11, 13, 15, 17, 20, and 23mm and have a total length of 17mm. The cement restrictor is to be used for cement implantation. This b-One Cement Restrictor is intended to restrict bone cement migration into the distal medullary canal and aid in cement pressurization during total hip arthroplasty.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the b-ONE® Total Hip System, which primarily discusses the substantial equivalence of the subject device to legally marketed predicate devices.
The content focuses on:
- The FDA's decision regarding the 510(k) submission (K240528).
- Regulatory information, classifications, and requirements for the device.
- Indications for Use for the b-ONE® Total Hip System.
- A comparison of technological characteristics with predicate devices.
- A list of non-clinical performance tests conducted, but not the acceptance criteria for these tests, nor the detailed results proving they were met.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or describe the study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) because that information is not present in the provided text.
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(448 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Hemi hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The SUMMIT POROCOAT Porous, SUMMIT DuoFix Porous, and SUMMIT Basic Press Fit stems are indicated for uncemented use only.
The SUMMIT Cemented and SUMMIT Basic Cemented stems are indicated for cemented use only.
The Summit Hip System is series of tapered femoral hip stems which may be used in either total or hemi-hip arthroplasty procedures in conjunction with DePuy hip arthroplasty devices.
The Summit Porous Hip Prosthesis is a series of collarless, titanium, tapered, press fit femoral stems The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit DuoFix Porous Hip Prosthesis is a series of collarless, titanium alloy, tapered, press-fit femoral stems. The hip stem is manufactured from titanium alloy (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem with a thin layer of hydroxyapatite (HA) coating. There are 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options. These stems are intended for uncemented use only.
The Summit Cemented Hip Prosthesis is series a flanged, collared tapered Cobalt-Chromium femoral stems with a smooth finish. There are seven proportional body sizes with a standard offset, and six proportional body sizes with a high offset. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Cemented Hip Prosthesis is a series of flanged, collared, tapered Cobalt-Chromium-Molybdenum femoral stems with a smooth surface finish. There are seven total sizes with a constant offset. Only six of the seven sizes are available in the high offset option. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. These stems are intended for cemented use only.
The Summit Basic Press Fit Hip Prosthesis is a series of collared, tapered Titanium femoral stem with a grit-blasted finish. There are seven sizes with a constant offset and a distal centralizer to assure that the stem is centered in the femoral canal. These stems are intended for uncemented use only.
This is a 510(k) summary for the Summit Hip System, which is a medical device. This document does not describe acceptance criteria for an AI/ML device, nor does it contain information about a study proving such a device meets acceptance criteria. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence of the Summit Hip System to predicate devices.
Therefore, I cannot answer your request based on the provided text as it does not contain the information you are looking for.
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