(76 days)
The Osteonics All Polyethylene Shoulder Glenoid Components are single-use devices. They are intended for cemented fixation within the prepared glenoid fossa of the shoulder. The Osteonics All Polyethylene Glenoid Shoulder Components, in conjunction with their mating humeral components, are intended for total shoulder arthroplasty. The indications for use are as follows: Aseptic necrosis of the humeral head. Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. Proximal humeral fracture and/or dislocation. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The keeled Osteonics All Polyethylene Glenoid Shoulder Component is intended for cemented fixation within the surgically prepared glenoid fossa of the shoulder. The Osteonics" All Polyethylene Glenoid Shoulder Component is shaped to conform to the geometry of the glenoid fossa. Its medial surface is curved so that, when placed against the prepared glenoid cavity, the device conforms to the shape of the cavity. This conformity allows less bone removal and may provide the component with added stability. The spherical radius of the bearing surface Osteonics All Polyethylene Glenoid Shoulder Component is larger than the spherical radius of the mating humeral head. This is intended to allow translation. The Osteonics" All Polyethylene Glenoid Shoulder Component comes in a range of sizes. Each component features a pre-assembled, x-ray marking wire on its medial surface. Each component features a keeled fixation post. The body of the Osteonics" All Polyethylene Glenoid Shoulder Component is manufactured from ASTM F-648 ultra-high molecular weight polyethylene (UHMWPE). The x-ray marking wire is manufactured from ASTM F-90 cobalt chromium alloy.
This 510(k) premarket notification describes a medical device, the Osteonics® All Polyethylene Glenoid Shoulder Component. However, the provided text does not contain any information regarding specific acceptance criteria, study data, or performance metrics that would allow me to populate the requested table or answer the detailed questions about a study proving the device meets acceptance criteria.
The document focuses on:
- Submission Information: Basic details about the sponsor and device.
- Predicate Device Identification: Listing similar devices already on the market.
- Device Description: Physical characteristics, materials, and intended use.
- Statement of Technological Comparison: Comparing the new device to predicates in terms of materials, design, and intended use to establish substantial equivalence.
Therefore, I cannot provide the requested information based on the provided text.
To answer your questions, I would need a section of the 510(k) or an accompanying study report that details:
- Specific performance objectives or requirements (acceptance criteria).
- Results from testing (e.g., mechanical testing, wear testing, clinical results).
- Details about the study design, sample sizes, ground truth establishment, etc.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”