(33 days)
The Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and nonrepairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of the devices if sufficient bone stock remains
The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if: - The Diaphyseal stem is well fixed
- The patient has a functional deltoid muscle
- The arthropathy is associated with a massive and non-repairable rotator cuff-tear.
Notes: - All components are single use
- The humeral stem is intended for cemented or cementless use
- The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
The Aequalis Ascend Modular Reverse shoulder prosthesis is a component of semi-constrained reverse shoulder prosthesis.
The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided are:
- The Modular Reverse Metaphysis and Modular Reverse Assembly Screw
- The Modular Reverse Inserts
- An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
- When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
The present device submission corresponds to changes made to the version of the device cleared in 510(k) K110599.
The provided text describes a medical device called the "Aequalis Ascend Modular Reverse Shoulder System" and its indications for use, but it does not contain information about acceptance criteria for a study, performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.
The document is a 510(k) premarket notification letter from the FDA to Tornier, Incorporated, confirming substantial equivalence to a predicate device. It outlines the device's classification, indications for use, and a summary of safety and effectiveness information, which primarily focuses on non-clinical testing (fatigue and insert disassembly testing) to demonstrate substantial equivalence to a legally marketed predicate device (Tornier Aequalis Ascend Modular Reverse Shoulder System, K110599).
Therefore, I cannot fulfill your request for the detailed table and study information as the provided text does not contain that level of detail regarding device performance or clinical study methodologies.
§ 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.”