(154 days)
Medacta Shoulder System - Reverse
Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint, severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application of screws for primary stability.
Short Humeral Diaphysis
The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Medacta Shoulder System - Anatomic
Anatomic Shoulder Prosthesis
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
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 component is intended for cemented application.
Short Humeral Diaphysis
The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally 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 component is intended for cemented application.
The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis).
The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems.
The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed.
The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.
This device is a medical implant, not an AI/ML device, therefore, the requested information regarding acceptance criteria and study details related to AI/ML performance is not applicable. The provided text is an FDA 510(k) clearance letter and summary for a physical medical device: the Medacta Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, which are different from the criteria typically found in AI/ML device evaluations.
However, I can provide a summary of the performance data that was provided in support of the substantial equivalence determination for this medical device, as described in the document.
Performance Data Provided:
The 510(k) summary lists the following performance data:
- Sterilization Validation: Per UNI EN ISO 11137-1:2015 and AAMI/ANSI/ISO 11137-2:2013. This ensures the device can be properly sterilized for safe use.
- Fatigue Testing: Per ASTM F1378-17. This evaluates the device's mechanical durability and its ability to withstand repeated stress over time, simulating conditions within the human body.
- Cadaver Studies: These studies typically assess surgical technique, implant fit, and preliminary biomechanical performance within an anatomical context.
Please note that none of the specific AI/ML related questions (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are relevant to the information presented in this 510(k) summary for the Medacta Shoulder System.
§ 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.”