(32 days)
The Biomet 100% porous coated Biaxial Hinge Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.
This device is a single use implant. It is intended for use with bone cement.
The Biomet 100% porous coated Biaxial Hinge Total Elbow Prosthesis is a constrained hinge elbow prosthesis used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two components, an ulnar and a humeral component which are joined by a modular connecting piece.
The Biaxial is a "loose hinge" type that has a parallel acting second axis of articulation between the ulnar and humeral stems. An inherent characteristic of the biaxial articulation is that it can vary the anterior-posterior offset between the intramedullary stems. The Biaxial Elbow allows the stem offset to vary because of varying amounts of flexion between the displaced axes of the prosthesis. The mechanical constraint of the articulation allows a total of 16 degrees of varus valgus movement, 6 degrees of hyperextension, and 188 degrees of flexion.
The humeral component is a titanium alloy stem. The humeral stem incorporates a flange on the anterior side for additional fixation. The entire stem and a portion of the flanges are plasma spray coated. The humeral component utilizes a polyethylene humeral bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.
The ulnar component is a titanium alloy stem. The surface of the ulnar component is plasma spray coated. The ulnar component utilizes a polyethylene ulnar bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.
The modular connecting segment is a cobalt chromium alloy metallic piece with a polished finish. The connecting segment is joined to the humeral and ulnar stems by means of a sleeve bearing metal reinforcing rod or axle and saddle bearing. The metal reinforcing rod or axle is manufactured from cobalt chromium. The axles are sleeved by axle bearings, which are manufactured from ArCom® (ultra high molecular weight polyethylene (UHMWPE)). The axle retaining clips are manufactured from titanium alloy. The saddle bearings of the humeral and ulnar component are manufactured from ArCom®.
This document is a 510(k) premarket notification for a medical device (Biomet 100% porous coated Biaxial Total Elbow). It establishes substantial equivalence to predicate devices and outlines the device's description, intended use, and potential risks. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria as typically found in clinical trial reports or performance validation studies for AI/software devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth for a test set.
- Sample size for the training set or how ground truth for the training set was established.
This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria.
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”