(145 days)
The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.
The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
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A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
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Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder athroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
The Humeral Cup Stability and the Humeral Cup 135 / 145° Stability are components that are added to the Humelock II Reversible Shoulder System, the Humelock Reverse Shoulder and Humeris Shoulder, when used as a reverse shoulder replacement. The Humeral Cup and the Humeral Cup 135 / 145°. Mobility and Standard, were previously cleared for use in the U.S. in the Humelock II Reversible Shoulder System (K150488), and included as compatible components in the Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct. The 32mm Glenosphere and Cups were added to the reverse shoulder systems in K192206. These reverse total shoulder systems are used in patients with a non-functional rotator cuff and have an inverted articulation such that the ball of the articulation is on the glenoid side and the mating humeral cup is part of the humeral side of the construct, which includes either a cemented or cementless humeral stem. Depending on the humeral stem used, the humeral cup may be fixed to the humeral stem using a 135 / 145° Reverse Adapter. All mating components specific to each system are described in the respective cleared 510(k) submissions.
The predicate humeral cups, the Humeral Cup and the Humeral Cup 135 / 145°, are onepiece constructs consisting of a pre-assembled Ti-6Al-4V allov shell (ISO 5832-3) and a UHMWPE insert (ISO 5834-1 and ISO 5834-2). Both humeral cups are available in 32mm, 36mm and 40mm to articulate with the glenosphere of the same size (K150488) and come in heights of +3mm, +6mm, and +9mm.
The predicate humeral cups vary in depth providing different amounts of constraint and articulation. This submission is for the Stability variant of the Humelock Reverse Humeral Cup and 135 / 145° Humelock Reverse Humeral Cup and is a component added to the Humelock II Reversible Shoulder System (K150488), Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct.
The provided text is a 510(k) premarket notification for a medical device: Humeral Cup Stability & Humeral Cup 135/145° Stability. This document is a regulatory filing, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria.
Specifically, the document states: "Clinical testing was not necessary to determine substantial equivalence of the Humeral Cup Stability to the predicate devices." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with acceptance criteria, human subjects, ground truth establishment, or multi-reader studies.
Therefore, I cannot provide the requested information, such as a table of acceptance criteria and reported device performance based on a human study, sample sizes for test sets, data provenance, number of experts, adjudication methods, or MRMC study details, because such a study was not conducted or presented in this regulatory filing.
The document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through:
- Comparison of Indications for Use: The new device's intended uses are compared to those of the predicate devices.
- Comparison of Fundamental Scientific Technology: The underlying principles and mechanisms are deemed similar.
- Material, Function, Manufacturing Processes, Shelf Life, Sterilization, Packaging, Instructions for Use, and Surgical Technique: These aspects are compared and shown to be similar or identical.
- Non-Clinical Testing: The document mentions mechanical testing to ASTM F2028-2017 and range of motion analysis, demonstrating that the device performs similarly to predicate devices and does not raise new questions of safety and effectiveness.
In summary, the provided document is a regulatory submission for premarket clearance via the 510(k) pathway, not a detailed report of a clinical study or a study designed to prove acceptance criteria through human performance data.
§ 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.”