(268 days)
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total shoulder arthroplasty are as follows:
- · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
- · Congenital abnormalities in the skeletally mature
- · Primary and secondary necrosis of the humeral head
- · Pathologies where arthrodesis or re sectional 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)
- · To restore mobility from previous procedures (e.g. previous fusion)
In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.
The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.
This FDA 510(k) K192097 premarket notification is for a medical device called the Exactech® Equinoxe® Stemless Humeral Components. It is an orthopedic implant for shoulder arthroplasty.
It's important to note that this document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering analyses and non-clinical testing. It does not involve studies with human subjects, AI algorithms, or deep learning models. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone AI performance, training set sample size) are not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail numerical sense for each test. Instead, it states that the devices "perform as intended and are substantially equivalent to the identified predicate devices" based on the non-clinical testing. The "reported device performance" is the conclusion that the device passes these tests, thereby demonstrating substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Demonstrate acceptable fatigue resistance. | Passed Fatigue Testing (details not provided in summary). |
| Demonstrate acceptable resistance to axial pull-out. | Passed Axial Pull Out Testing (details not provided). |
| Demonstrate acceptable resistance to torque-out. | Passed Torque out Testing (details not provided). |
| Demonstrate acceptable resistance to taper disengagement. | Passed Taper Disengagement Testing (details not provided). |
| Characterize porous structure to ensure appropriate properties. | Passed Porous Structure Characterization (details not provided). |
| Meet pyrogen limits (sterility requirements). | Passed Pyrogen testing in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72. |
| Comparable indications for use to predicate. | "The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices have similar indications for use." |
| Comparable materials/surface finish/coatings to predicate. | "The proposed Exactech Equinoxe Stemless Humeral Components and the predicate devices are composed of the similar biocompatible substrate materials, and the same or similar surface finish for permanent implants." |
| Comparable design features to predicate. | "The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices have similar design features." |
| Dimensionally comparable to predicate. | "The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices are dimensionally comparable." |
| Provided sterile for single use, comparable to predicate. | "The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices are provided sterile for single use only." |
| Conform to recognized performance standards for total shoulder replacement. | "The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices conform to recognized performance standards for total shoulder replacement devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for fatigue). These would typically be determined by relevant ASTM or ISO standards for testing orthopedic implants, but are not detailed in this summary.
- Data Provenance: Not applicable in the context of this device. The "data" comes from engineering and laboratory testing of the physical device components, not from patient data or clinical images. It's not retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context is established by physical measurement against engineering specifications and industry standards for material properties, mechanical performance, and sterilization. It doesn't involve clinical experts establishing diagnoses or observations.
4. Adjudication Method for the Test Set
Not applicable. There's no "test set" in the sense of clinical cases requiring adjudication. The tests are physical and chemical evaluations.
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 physical orthopedic implant, not an AI-powered diagnostic or assistive device for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- Established mechanical engineering principles.
- Relevant ASTM/ISO International Standards for orthopedic implants.
- FDA Guidance Documents (e.g., for sterility).
- Material specifications (e.g., for Ti-6Al-4V).
- Functional requirements for shoulder replacement devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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April 29, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Exactech, Inc. Zach Sharrah Manager, Regulatory Affairs 2320 NW 66th Court GAINSVILLE, FL 32653
Re: K192097
Trade/Device Name: Exactech® Equinoxe® Stemless Humeral Components Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: March 26, 2020 Received: March 30, 2020
Dear Zach Sharrah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192097
Device Name Exactech® Equinoxe® Stemless Humeral Components
Indications for Use (Describe)
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total shoulder arthroplasty are as follows:
- · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
- · Congenital abnormalities in the skeletally mature
- · Primary and secondary necrosis of the humeral head
- · Pathologies where arthrodesis or re sectional 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)
- · To restore mobility from previous procedures (e.g. previous fusion)
In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Exactech® Equinoxe® Stemless Humeral Components Traditional 510(k) - 510(k) Summary
| Company: | Exactech®, Inc2320 NW 66th CourtGainesville, FL 32653 |
|---|---|
| Date: | July 30, 2019 |
| Contact Person: | Zach SharrahManager, Regulatory Affairs |
| Phone: (352) 377-1140Fax: (352) 378-2617 | |
| Proprietary Name: | Exactech® Equinoxe® Stemless Humeral Components |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Total Anatomic Shoulder, UncementedMetaphyseal Humeral Stem with No Diaphyseal Incursion,Semi-Constrained, 21 CFR 888.3660, Class II, ProductCode PKC |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- o Exactech Equinoxe Stemless Shoulder (K173388)
Reference Devices
Device Description
The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.
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Exactech® Equinoxe® Stemless Humeral Components Traditional 510(k) – 510(k) Summarv
Indications for Use
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total shoulder arthroplasty are as follows:
- Osteoarthritis, osteonecrosis or post-traumatic degenerative problems ●
- Congenital abnormalities in the skeletally mature
- Primary and secondary necrosis of the humeral head.
- Pathologies where arthrodesis or re sectional arthroplasty of the humeral head are ● not acceptable
- o Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
- To restore mobility from previous procedures (e.g. previous fusion)
In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- o Indications for Use. The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices have similar indications for use.
- Materials/Surface Finish/Coatings. The proposed Exactech Equinoxe Stemless ● Humeral Components and the predicate devices are composed of the similar biocompatible substrate materials, and the same or similar surface finish for permanent implants.
- Design Features. The proposed Exactech Equinoxe Stemless Shoulder ● components and the predicate devices have similar design features.
- Dimensions. The proposed Exactech Equinoxe Stemless Shoulder components ● and the predicate devices are dimensionally comparable.
- 0 Sterilization. The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices are provided sterile for single use only.
- o Performance Requirements. The proposed Exactech Equinoxe Stemless Shoulder components and the predicate devices conform to recognized performance standards for total shoulder replacement devices.
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Exactech® Equinoxe® Stemless Humeral Components Traditional 510(k) – 510(k) Summarv
Non-Clinical Testing
The following engineering analyses were performed to demonstrate that the Exactech Equinoxe Stemless Shoulder perform as intended and are substantially equivalent to the identified predicate devices:
- Fatigue Testing ●
- Axial Pull Out Testing ●
- Torque out Testing
- Taper Disengagement Testing
- o Porous Structure Characterization
Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Equinoxe Stemless Shoulder components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech Equinoxe Stemless Shoulder demonstrates substantial equivalence to the referenced predicate devices.
§ 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.”