(232 days)
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement and a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid baseplate is intended for cementless application of screws for primary stability.
The Medacta Shoulder System is a modular system intended to be used for Reverse Shoulder Arthroplastises (RSA). The Medacta Shoulder System is composed of the following components:
- Humeral Diaphysis Cemented
- Humeral Diaphysis - Cementless
- Humeral Reverse Metaphysis
- Humeral Reverse HC Liner (also referred to as PE Liner)
- Glenoid Baseplate
- Glenoidsphere
- Glenoid Polyaxial Locking Screws
- Reverse Metaphysis Screw
- Glenoidsphere Screw
The Humeral Diaphysis and Humeral Reverse Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis.
The Glenoid Baseplate is intended to be fixed on the glenoid bone by means of a central press-fit and with the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with the Glenoid Baseplate by means of a taper Morse connection and secured by the Glenoidsphere Screw.
The Glenoidsphere Screw, Reverse Metaphysis Screw, and Glenoid Polyaxial Locking Screws are made of Ti alloy enhanced with Type-II anodization.
This document is a 510(k) summary for the Medacta Shoulder System, a medical device. It does not describe an AI/ML device, nor does it present acceptance criteria or a study proving that an AI/ML device meets those criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies for an AI/ML device from this document.
The document discusses the substantial equivalence of the Medacta Shoulder System to predicate devices based on:
- Indications for Use: The Medacta Shoulder System is indicated for treatment of humeral fractures and primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement and a grossly deficient rotator cuff shoulder joint.
- Technological Characteristics: Similarities in materials (Titanium Alloy, Cobalt Chromium, UHMWPE), design, coating, thread design, device usage, and sterility to predicate devices.
- Non-Clinical Studies: Mechanical tests (Wear, Fatigue, Static Fatigue, Micromotions Assessment), and Coating Tests following ASTM standards.
- Biocompatibility: Demonstrated through similarities in materials to predicate devices and adherence to manufacturing standards.
- Pyrogenicity: Assessed using Bacterial Endotoxin Test (LAL test) and Pyrogen Test according to European Pharmacopoeia and USP chapters.
No clinical studies were conducted for the Medacta Shoulder System to support the 510(k) submission.
§ 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.”