(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 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 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/R) 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 (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.
The Equinoxe Shoulder System is comprised of primary, fracture and reverse product lines for use in hemi- and total-shoulder joint replacement procedures. The Equinoxe Primary and Fracture system utilize both cemented and press-fit, semi-constrained glenohumeral prostheses for use in hemi-shoulder and totalshoulder joint replacement procedures, and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus.
The Equinoxe Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional rotator cuff. The Equinoxe Reverse Shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems.
The proposed fixed angle replicator plates are manufactured from wrought titanium alloy (Ti-6Al-4V E.L.I) per ASTM F136 and connect to the humeral stem via a spherical bowl and are locked in place using the previously cleared primary torque-defining screw. The replicator plate attaches to the humeral head using a morse taper. The mating features on the proposed replicator plates (specifically the morse taper geometry and the spherical bowl geometry) are identical to the predicate part, only the offset and angular adjustability have been altered.
The proposed humeral heads are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75 and provide an articulating surface for hemi and total joint replacement. They feature female taper geometry for mating with proposed and predicate replicator plate designs. No design changes have been made to this device. It is a material change only.
The proposed glenospheres are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75and connect to the plate via an apical hole screw and slip fit with oval shaped plate. No design changes have been made to this device. It is a material change only.
The provided text describes a Special 510(k) submission for the Exactech Equinoxe Fixed-Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a novel device through a clinical study.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, and ground truth establishment cannot be fully extracted as it is not the nature of this type of submission.
Instead, the submission relies on demonstrating that the new devices are as safe and effective as their predicate devices through comparisons of materials, design, dimensions, intended use, packaging, sterilization, and shelf life, supported by non-clinical performance data (fatigue testing).
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in the manner typically seen for clinical studies. Instead, the "acceptance criterion" is implicitly substantial equivalence to predicate devices in terms of design, materials, intended use, and mechanical performance.
| Criterion | Reported Device Performance |
|---|---|
| Intended Use / Indications for Use | Fixed Angle Replicator Plate: Identical to predicate devices for total shoulder joint replacement. |
| Cast Humeral Heads: Identical to predicate devices for total shoulder joint replacement. | |
| Cast Glenospheres: Identical to predicate devices for reverse total shoulder joint replacement. | |
| Materials | Fixed Angle Replicator Plate: Wrought titanium alloy (Ti-6Al-4V E.L.I) per ASTM F136; equivalent biocompatible materials conforming to recognized industry standards for permanent implants (compared to predicate). |
| Cast Humeral Heads: Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75; biocompatible materials conforming to recognized industry standards for permanent implants (compared to predicate). | |
| Cast Glenospheres: Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75; biocompatible materials conforming to recognized industry standards for permanent implants (compared to predicate). | |
| Design Features | Fixed Angle Replicator Plate: Same design features as predicate devices. |
| Cast Humeral Heads: Same design features as predicate devices. | |
| Cast Glenospheres: Same design features as predicate devices. | |
| Dimensions | Fixed Angle Replicator Plate: Identical geometry for mating with cleared humeral stems and humeral heads. Differences: new offset option and reduced through-hole diameter to prevent angulation (stated to have no effect on mechanical strength). |
| Cast Humeral Heads: Identical geometry to predicate devices. | |
| Cast Glenospheres: Identical geometry to predicate devices. | |
| Packaging and Sterilization | All Devices: Same materials and processes as predicate devices. |
| Device Shelf Life | All Devices: Same shelf life as predicate devices. |
| Non-Clinical Performance Data | Fatigue testing: Conducted to verify safety and effectiveness of the proposed devices, specifically mitigating risks affected by the proposed changes. Results presented within the 510(k) demonstrated substantial equivalence. (Specific numerical results are not provided in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This document refers to non-clinical (fatigue) testing, not a clinical test set. The number of samples for fatigue testing is not specified in the summary.
- Data Provenance: Not applicable for clinical data. The fatigue testing is likely laboratory-based data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) for orthopedic implants, not an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a 510(k) for orthopedic implants, not an AI/imaging device requiring adjudication.
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
Not applicable. This is a 510(k) for orthopedic implants, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for orthopedic implants, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this submission is based on the performance and safety profiles of the legally marketed predicate devices, and demonstrated through non-clinical (fatigue) testing.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.”