(89 days)
The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate. For Cemented Use Only
The Comprehensive Humeral Fracture Positioning Sleeve is composed of Polymethyimethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System (K023063). The device is a sleeve that fits over the distal tapered stem of the Comprehensive Fracture system and stops at a point below the fins of the stem.
The provided text is a 510(k) summary for the Biomet Comprehensive Humeral Fracture Positioning Sleeve. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, as no such study or criteria are detailed in the provided documents.
The document indicates that an "engineering justification was utilized to determine that no additional mechanical testing was required." This suggests that mechanical testing results might exist supporting the device's equivalence, but these are not disclosed with specific acceptance criteria or performance data in this summary.
In summary, based on the provided text, the device's clearance was based on substantial equivalence to predicate devices and an engineering justification, not on a clinical study demonstrating performance against specific acceptance criteria.
§ 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.”