(32 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 hemiarthroplasty 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 wellfixed/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:
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 (hemiarthroplasty), 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.
The proposed Equinoxe extra short humeral heads represent a modification to Equinoxe short humeral heads cleared per 510(k) K042021. Both predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between predicate and proposed devices are the following dimensional modifications:
- Proposed device thickness is decreased by 3mm.
- Proposed device female taper length is reduced by 5mm.
- Proposed device female taper length is offset, where only 44mm and 47mm predicate devices feature offset female taper lengths.
These modifications are proposed to provide surgeons with additional options for matching variation in patient anatomical needs.
Acceptance Criteria and Device Performance for Exactech® Equinoxe® Extra Short Humeral Heads
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Equinoxe Short Humeral Heads, K042021) rather than establishing specific, quantitative performance acceptance criteria in the classical sense (e.g., a specific accuracy threshold). Instead, the acceptance criteria are implicitly that the modified device performs comparably to or better than the predicate device in relevant engineering tests, demonstrating that the dimensional changes do not compromise safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Integrity (Cyclic Fatigue): The extra short humeral heads maintain structural integrity and resistance to fatigue under cyclic loading, comparable to the predicate device. | Cyclic fatigue testing was conducted. The summary states that these tests were performed to "demonstrate substantial equivalence." While specific pass/fail criteria or comparative load cycles are not detailed in this summary, the conclusion of substantial equivalence implies that the extra short humeral heads performed acceptably, likely meeting or exceeding the predicate's performance under similar conditions. |
| Secure Attachment (Axial Pull-off): The extra short humeral heads maintain a secure attachment to the humeral stem, comparable to the predicate device, especially considering the reduced female taper length. | Axial pull-off testing was conducted. Similar to fatigue testing, the purpose was to "demonstrate substantial equivalence." This indicates that the force required to dislodge the head from the stem was acceptable and likely comparable to the predicate device, despite the taper length reduction. |
| Surgical Feasibility and Clinical Appropriateness: The dimensional modifications (decreased thickness, reduced and offset female taper length) allow for successful implantation and provide surgeons with appropriate options for patient anatomical needs, without introducing new surgical complications. | Surgical evaluation/cadaveric validation was performed. The purpose of the modifications is "to provide surgeons with additional options for matching variation in patient anatomical needs." The validation implies that the modified heads were found to be surgically feasible and appropriate for their intended use in cadaveric settings, confirming their utility in addressing anatomical variations. |
2. Sample Size and Data Provenance
The document does not specify exact sample sizes for the mechanical tests (cyclic fatigue and axial pull-off) or the surgical evaluation/cadaveric validation.
- Test Set: Not explicitly stated. The tests are engineering analyses rather than clinical trials with patient-based test sets.
- Data Provenance: The tests are described as "engineering analyses" and "cadaveric validation," suggesting they were conducted in a laboratory or simulated environment, likely in the country where Exactech, Inc. is located (USA). The data would be prospective in the sense that these tests were specifically designed and executed for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated for establishing ground truth for the test set.
- Qualifications of Experts: For the "surgical evaluation/cadaveric validation," the experts would be surgeons or individuals with relevant surgical expertise, likely orthopedic surgeons specializing in shoulder arthroplasty, performing the cadaveric procedures. Specific qualifications (e.g., years of experience) are not provided in the summary.
4. Adjudication Method
Not applicable. The reported studies are laboratory-based engineering tests and cadaveric validation, not clinical studies that typically involve adjudication of patient outcomes or imaging interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) Special submission for a dimensional modification of an existing device. The studies conducted are non-clinical (mechanical and cadaveric) to demonstrate substantial equivalence, not a clinical MRMC study. Therefore, there is no effect size reported for human readers with or without AI assistance.
6. Standalone Performance (Algorithm Only)
No. This device is a physical medical implant (humeral head), not an algorithm or AI-powered diagnostic tool. Standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the mechanical tests would be the established engineering standards, material properties, and performance characteristics of the predicate device. For the cadaveric validation, the "ground truth" would be the successful and safe surgical handling, fit, and biomechanical interaction observed during the cadaveric procedure, as assessed by expert surgeons. It is based on engineering benchmarks and expert observation/assessment, not pathology, patient outcomes, or expert consensus in interpreting clinical data.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.”