(30 days)
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used with . bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications or in . revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | |
| √ | √ | Congenital abnormalities in the skeletally mature | |
| √ | Primary and secondary necrosis of the humeral head. | ||
| √ | Humeral head fracture with displacement of the tuberosities | ||
| √ | √ | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | |
| √ | √ | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | |
| √ | Displaced three-part and four-part upper humeral fractures | ||
| √ | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | ||
| √ | Revision of failed previous reconstructions when distal anchorage is required | ||
| √ | √ | To restore mobility from previous procedures (e.g. previous fusion) |
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
This submission proposes modifying Exactech Equinoxe Cage Glenoid devices cleared via 510(k) #K093430 to change peg geometry and add plasma coating. The proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021 and 510(k) #K061454 as cited predicates.
The provided text describes a Special 510(k) submission for the Exactech Equinoxe® Cage Glenoids™, which proposes modifications to previously cleared devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Exactech Equinoxe Cage Glenoid, K093430) through non-clinical performance data.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the mechanical testing standards and the conclusion of substantial equivalence. The "reported device performance" is a statement that the device met these criteria, rather than specific numerical results.
| Acceptance Criterion (Implied by Test Standard) | Reported Device Performance |
|---|---|
| Mechanical glenoid loosening/disassociation (ASTM F2028) | Test results demonstrate substantial equivalence. |
| Axial disassembly of modular pegs | Test results demonstrate substantial equivalence. |
| Resistance of locking mechanism to shear and bending | Test results demonstrate substantial equivalence. |
| Plasma coating shear fatigue strength (ASTM F1160) | Test results demonstrate substantial equivalence. |
| Plasma coating static shear strength (ASTM F1044) | Test results demonstrate substantial equivalence. |
| Plasma coating static tensile strength (ASTM F1147) | Test results demonstrate substantial equivalence. |
| Plasma coating abrasion (ASTM F1978) | Test results demonstrate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "test results and analyses," which are typically derived from a specific number of samples for each mechanical test, but the exact number of units tested for each criterion is not provided.
- Data Provenance: Not explicitly stated regarding country of origin. The study is a non-clinical performance study (mechanical testing), not a study involving patient data. Therefore, the concepts of "retrospective or prospective" and "country of origin of the data" are not directly applicable in the same way they would be for a clinical study. These are laboratory-based engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for non-clinical mechanical testing is established by adherence to recognized industry standards (e.g., ASTM standards) and the physical properties and performance of the device under specific test conditions. Expert opinion is not used to establish the "ground truth" in the same way it would be for a clinical diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human interpretation or subjective assessments, often in diagnostic imaging. Mechanical testing results are objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This submission is for modifications to a glenoid component (a medical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device (implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is based on:
- Adherence to recognized industry standards: Specifically, various ASTM standards for mechanical testing (e.g., F2028, F1160, F1044, F1147, F1978). These standards define the test methods and often acceptable performance ranges for similar devices.
- Comparison to the predicate device: The fundamental "ground truth" for a 510(k) submission, especially a Special 510(k) for modifications, is demonstrating that the modified device performs equivalently to a legally marketed predicate device, as confirmed by comparing design features, materials, dimensions, and mechanical performance under the same test conditions.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of mechanical testing for a medical implant. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.”