(44 days)
The Aequalis Reversed Shoulder Prosthesis is indicated for patients, with a functional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.
The Aequalis Reversed Shoulder Prosities humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glonoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Reversed prosthesis in to a non reversed hemi-prosthesis.
When, in case of revision of a Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Reversed prosthesis in to an anatomical non reversed hemiprosthesis in order to avoid the revision of the humeral components.
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres pinor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to mcdialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification submission consists in the addition of components to the Aequalis Reversed Soulder prosibesis in order to have the possibility to transform the Aequalis Reversed Soulder Prosthesis in a standard hemi or total prosthesis in some clinical cases encountered during the surgical procedure.
The present Device Modification submission corresponds to the addition of 3 components of the Aequalis Reversed Shoulder prosthesis:
- Hemi-prosthesis adaptor diameter 36 mm, -
- Hemi-prosthesis adaptor diameter 42 mm, -
- Adaptor metaphysis union screw.
The provided document is a 510(k) premarket notification for a medical device, specifically the AEQUALIS Reversed Shoulder Prosthesis, and does not contain any information about acceptance criteria or a study proving that a device meets such criteria.
This document describes:
- The device name, classification, and submitter information.
- A description of the device and its intended use.
- Materials used in its construction.
- Indications for use for the original device and the added components.
- A letter from the FDA determining substantial equivalence to predicate devices, thus allowing the device to be marketed.
Since the document provided is a 510(k) submission, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results. The content is primarily descriptive and regulatory in nature. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this particular 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.”