Who is the manufacturer of Exactech® Equinoxe® Stemless Humeral Components?

Exactech, Inc. filed the 510(k) submission for Exactech® Equinoxe® Stemless Humeral Components (K192097).

What is the FDA product code for Exactech® Equinoxe® Stemless Humeral Components?

PKC. It is classified under 21 CFR 888.3660 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Exactech® Equinoxe® Stemless Humeral Components?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Exactech® Equinoxe® Stemless Humeral Components?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Exactech® Equinoxe® Stemless Humeral Components

Q: What are the predicate devices for Exactech® Equinoxe® Stemless Humeral Components?

Exactech Equinoxe Stemless Shoulder (K173388).

K192097 · Exactech, Inc. · PKC · Apr 29, 2020 · Orthopedic

Device Facts

Record ID	K192097
Device Name	Exactech® Equinoxe® Stemless Humeral Components
Applicant	Exactech, Inc.
Product Code	PKC · Orthopedic
Decision Date	Apr 29, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3660
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

The Equinoxe Stemless Humeral Components are orthopedic implants used in total shoulder arthroplasty. The device is a stemless humeral component designed for press-fit, uncemented fixation into the humerus. It is used in conjunction with Equinoxe humeral heads and cemented Equinoxe glenoid components. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. It functions by replacing the humeral head to restore joint mobility and function in patients with degenerative joint disease. The device is provided sterile for single use. Clinical benefit is derived from restoring joint function and reducing pain associated with degenerative shoulder conditions.

Clinical Evidence

Bench testing only. Engineering analyses performed include fatigue testing, axial pull-out testing, torque-out testing, taper disengagement testing, and porous structure characterization. Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Additively manufactured Ti-6Al-4V substrate with porous regions. Available in three sizes (17mm to 24mm lengths). Designed for press-fit, uncemented fixation. Provided sterile for single use. Conforms to recognized performance standards for total shoulder replacement devices.

Indications for Use

Indicated for skeletally mature individuals with degenerative glenohumeral joint disease requiring anatomic total shoulder arthroplasty. Includes osteoarthritis, osteonecrosis, post-traumatic degeneration, congenital abnormalities, and revision cases where adequate fixation is achievable.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

Exactech Equinoxe Stemless Shoulder (K173388)

Reference Devices

Tornier Simpliciti Shoulder System (K143552)
Equinoxe Humeral Heads (K042021, K140063)

Submission Summary (Full Text)

{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) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 - Tornier Simpliciti Shoulder System (K143552) ● - Equinoxe Humeral Heads (K042021, K140063) ● ### 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. {5}------------------------------------------------ # 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.

Exactech® Equinoxe® Stemless Humeral Components

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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