(109 days)
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body - humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The Glenoid is intended for cemented use only.
Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from disability due to:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; ●
- Treatment of acute fractures of the humeral head that cannot be treated with other . fracture fixation methods;
- Cuff tear arthropathy. .
The SMR CTA Humeral Heads are made from CoCrMo (ISO 5832-12 / ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The articulating surface is polished. The only difference between the SMR CTA Humeral Heads and the humeral heads cleared in K100858 is the addition of a lateral flange to better accommodate the rotator cuff tear arthropaty patient.
The SMR CTA Humeral Heads are intended to be coupled to the humeral body by means of specific adaptor tapers. Humeral bodies are then assembled by taper coupling with humeral stems. When used in total shoulder replacement. the SMR CTA Humeral Heads are coupled with glenoid components. Humeral stems, humeral bodies, adaptor tapers and glenoid components are the same cleared in K100858 and K101263.
SMR CTA Humeral Heads can be used with both cemented and uncemented stems. Glenoid components are intended for cemented use only.
The device descriptions for the adaptor tapers, humeral bodies, humeral stems and glenoid components cleared via K100858 and K101263 are repeated here in italic typing for an understanding of the complete system.
Two designs of humeral stems are available: the first one is intended for uncemented use while the second one is intended for cemented use only.
Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal proximal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6A14V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.
Humeral bodies are available in two designs. The first one is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented and in uncemented applications. Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).
They are coupled with the humeral stem via a female Morse-taper connection stabilized with a locking screw. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.
Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V (ISO 5832-3, ASTM F1472). They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and to give the required offset to the humeral head in order to achieve the correct tensioning to the soft tissues, optimizing joint stability.
The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone (in hemi-arthroplasty) or with the glenoid component (total arthroplasty). The surface is polished in order to reduce wear.
Glenoids are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head. This allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation. Six cement pockets are also incorporated on the back surface of the glenoid to enhance cement fixation.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the SMR CTA Humeral Heads, detailing its description, intended use, comparison to predicate devices, and non-clinical testing performed. It explicitly states that "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR CTA Humeral Heads to the predicate device(s)."
Therefore, I cannot fulfill your request for the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. This information simply is not present in the provided text.
§ 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.”