(268 days)
No
The summary describes a mechanical implant for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a shoulder replacement system (Equinoxe Stemless Shoulder System), is indicated for treating degenerative diseases and other pathological conditions of the glenohumeral joint to restore mobility, fitting the definition of a therapeutic device.
No
The device description indicates that the Equinoxe Stemless Shoulder System is a prosthetic implant for shoulder arthroplasty, which is a treatment device, not a diagnostic one. Its stated purpose is for surgical intervention to replace a joint, not to diagnose a condition.
No
The device description clearly states the device is a physical implant (humeral components made of Ti-6Al-4V) and describes mechanical testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a surgical implant (a shoulder prosthesis) used to replace damaged parts of the glenohumeral joint. It is a physical device implanted into the body during surgery.
- Lack of Diagnostic Function: The device's purpose is to restore mobility and function to the shoulder joint, not to diagnose a condition based on analysis of biological samples.
The information provided clearly indicates this is a medical device used for surgical treatment, not an in vitro diagnostic test.
N/A
Intended Use / 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
- · 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.
Product codes (comma separated list FDA assigned to the subject device)
PKC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, shoulder
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Fatigue Testing
- Axial Pull Out Testing
- Torque out Testing
- Taper Disengagement Testing
- Porous Structure Characterization
Pyrogen testing was conducted in accordance with USP , USP , 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.
Key results: The performed analyses demonstrated that the Exactech Equinoxe Stemless Shoulder perform as intended and are substantially equivalent to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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
2
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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3
Exactech® Equinoxe® Stemless Humeral Components Traditional 510(k) - 510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 30, 2019 |
| Contact Person: | Zach Sharrah
Manager, Regulatory Affairs |
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Equinoxe® Stemless Humeral Components |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Total Anatomic Shoulder, Uncemented
Metaphyseal Humeral Stem with No Diaphyseal Incursion,
Semi-Constrained, 21 CFR 888.3660, Class II, Product
Code 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.
4
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 , USP , 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.