(130 days)
No
The document describes a physical implantable device (shoulder system) and its components, materials, and mechanical testing. There is no mention of software, algorithms, data analysis, or any terms related to AI/ML.
Yes
The device is indicated for use in individuals with degenerative diseases of the glenohumeral joint, aiming to restore mobility and treat various pathologies, which are therapeutic interventions.
No
This device is a shoulder implant system intended for total shoulder arthroplasty, which is a treatment for degenerative diseases of the glenohumeral joint. It is a prosthetic device, not one used for diagnosis.
No
The device description explicitly details physical components made of Ti-6Al-4V and Cobalt Chrome, which are hardware implants for shoulder arthroplasty.
Based on the provided information, 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.
- Device Description: The Equinoxe Stemless Shoulder System is a physical implant (humeral components and heads) designed to be surgically placed within the body to replace a damaged joint.
- Intended Use: The intended use is to treat degenerative diseases of the glenohumeral joint through surgical implantation (anatomic total shoulder arthroplasty). This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information clearly describes a surgical implant and its intended use in a surgical procedure, which falls outside the scope of in vitro diagnostics.
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 total shoulder arthroplasty is determined by 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 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)
- To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
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 Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).
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
Not Found
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
Pyrogen testing was conducted in accordance with USP , USP , and ANSVAAMI 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: 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.
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized depiction of a human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency written in blue text to the right of the square.
March 9, 2018
Exactech®, Inc Thomas Mcnamara Senior Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K173388
Trade/Device Name: Exactech® Equinoxe® Stemless Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: February 6, 2018 Received: February 7, 2018
Dear Thomas McNamara:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Thomas McNamara
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173388
Device Name
Exactech® Equinoxe® Stemless Shoulder
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 total shoulder arthroplasty is determined by 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 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)
- · To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
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 Shoulder Traditional 510(k) - 510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 6, 2018 |
| Contact Person: | Thomas McNamara, RAC
Senior Regulatory Specialist |
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Equinoxe® Stemless Shoulder |
| 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:
Reference Devices
- Exactech Equinoxe Resurfacing Humeral Head System (K131298) ●
- Exactech Novation® Crown Cup® with InteGrip™ Acetabluar Shell, Cluster-Hole o (K102975)
- Exactech Optetrak Logic® Metaphseal Cones (K153595) ●
Device Description
The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).
4
Exactech® Equinoxe® Stemless Shoulder Traditional 510(k) - 510(k) Summary
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 total 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 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)
- To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
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:
- . 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 Shoulder components and the predicate devices are composed of the same or 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.
- 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.
5
Exactech® Equinoxe® Stemless Shoulder Traditional 510(k) - 510(k) Summary
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 o
- Torque out Testing
- o Taper Disengagement Testing
Pyrogen testing was conducted in accordance with USP , USP , and ANSVAAMI 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.