(68 days)
No
The device description and performance studies focus on mechanical properties and anatomical fit of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty to address various medical conditions, including degenerative problems, fractures, and bone loss, with the goal of restoring mobility and improving joint mechanics.
No
The device is a humeral implant intended for surgical replacement in reverse shoulder arthroplasty, not for diagnosing conditions.
No
The device description clearly states that the device is comprised of physical components (humeral tray component, modular extension, universal locking screw) made from Titanium Alloy. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Equinoxe Humeral Augmented Tray is a surgical implant designed for proximal humeral replacement in reverse shoulder arthroplasty. It is a physical device implanted into the body to restore function and address bone loss.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens outside of the body.
Therefore, the Equinoxe Humeral Augmented Tray falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:
- · 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 humeral stem fixation can be achieved)
- · Displaced three- and four-part upper humeral fractures
- · Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
- Revision of failed previous reconstructions when distal anchorage is required
- · Treatment of unplanned proximal bone loss during a revision
- · To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS
Device Description
The Exactech Equinoxe Humeral Augmented Trays are intended for use in total shoulder arthroplasty in skeletally mature patients with proximal humeral bone loss. Specifically, Equinoxe Humeral Augmented Trays are used in combination with Equinoxe Reverse Shoulder System components to compensate for proximal humeral bone loss in presence of an intact medial calcar, irreparable or grossly deficient rotator cuff and a functional deltoid muscle. One of the overall goals of the anatomically designed Equinoxe Humeral Augmented Trays is to improve joint mechanics and stability by providing increased deltoid muscle wrapping and adequate soft tissue tensioning in patients with proximal humeral bone loss.
The Equinoxe Humeral Augmented Trays are consisted of a humeral tray component, a modular extension (augment) and a universal locking screw for use in primary and revision cases. To accommodate patients' various anatomical needs. Equinoxe Humeral Augmented Trays are anatomically designed with two offsets/thicknesses and multiple lateralizations of left and right humeral trays and left and right modular extensions. Per surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humeral
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)
The following mechanical testing, engineering analysis, and cadaveric evaluation were performed to demonstrate that the Exactech Equinoxe Humeral Augmented Trays perform as intended and are substantially equivalent to the identified predicate Equinoxe Humeral Adapter Trays previously cleared in K063569 and K082702:
- Fatigue strength testing under worst-case lateral loading
- Fatigue strength testing under worst-case medial loading
- Range of Motion Analysis
- Cadaveric evaluation
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Equinoxe Humeral Augmented Trays 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: Results of the non-clinical testing including mechanical testing, engineering analysis and cadaveric evaluation demonstrate the proposed Exactech Equinoxe Humeral Augmented Trays are substantially equivalent to the previously cleared Humeral Adapter Trays in the Exactech Equinoxe Reverse Shoulder System.
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
August 20, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Exactech, Inc Shing Jen Tai Principal Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K191561
Trade/Device Name: Exactech® Equinoxe® Humeral Augmented Trays Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS Dated: June 11, 2019 Received: June 13, 2019
Dear Shing Jen Tai:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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,
FOR Vesa Vuniqi 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191561
Device Name
Exactech® Equinoxe® Humeral Augmented Trays
Indications for Use (Describe)
The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:
- · 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 humeral stem fixation can be achieved)
- · Displaced three- and four-part upper humeral fractures
- · Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
- Revision of failed previous reconstructions when distal anchorage is required
- · Treatment of unplanned proximal bone loss during a revision
- · To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Exactech®Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary
| Sponsor: | Exactech®, Inc
2320 N.W. 66th Court
Gainesville, FL 32653 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact Person: | Shing Jen Tai, PhD
Principal Regulatory Affairs Specialist |
| Date: | August 8, 2019 |
| Proprietary Name: | Exactech® Equinoxe® Humeral Augmented Trays |
| Common Name: | Reverse shoulder prosthesis |
| Regulation Number: | 21 CFR 888.3650
21 CFR 888.3660 |
| Classification Name: | Shoulder joint metal/polymer non-constrained cemented
prosthesis
Shoulder joint metal/polymer semi-constrained cemented
prosthesis |
| Device Class: | Class II |
| Product Code: | PHX, KWT, KWS |
| Classification Panel: | Orthopedic |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K063569 | Equinoxe Reverse Shoulder System (Humeral | |
| Adapter Trays) | Exactech, Inc | |
| K082702 | Equinoxe Reverse Shoulder System + 15mm | |
| Humeral Adapter Tray | Exactech, Inc |
4
Exactech® Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary
Information on reference device:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K143659 | Equinoxe Humeral Reconstruction Prosthesis | Exactech, Inc |
Indications for Use
The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:
- 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 humeral stem fixation can be achieved)
- Displaced three- and four-part upper humeral fractures
- Failed ORIF requiring TTSA with an absent or deficient greater tuberosity ●
- Revision of failed previous reconstructions when distal anchorage is required ●
- Treatment of unplanned proximal bone loss during a revision
- To restore mobility from previous procedures (e.g. previous fusion) ●
The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.
De vice De scription
The Exactech Equinoxe Humeral Augmented Trays are intended for use in total shoulder arthroplasty in skeletally mature patients with proximal humeral bone loss. Specifically, Equinoxe Humeral Augmented Trays are used in combination with Equinoxe Reverse Shoulder System components to compensate for proximal humeral bone loss in presence of an intact medial calcar, irreparable or grossly deficient rotator cuff and a functional deltoid muscle. One of the overall goals of the anatomically designed Equinoxe Humeral Augmented Trays is to improve joint mechanics and stability by providing increased deltoid muscle wrapping and adequate soft tissue tensioning in patients with proximal humeral bone loss.
The Equinoxe Humeral Augmented Trays are consisted of a humeral tray component, a modular extension (augment) and a universal locking screw for use in primary and revision cases. To accommodate patients' various anatomical needs. Equinoxe Humeral Augmented Trays are anatomically designed with two offsets/thicknesses and multiple lateralizations of left and right humeral trays and left and right modular extensions. Per
5
Exactech® Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary
surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).
Non-Clinical Testing
The following mechanical testing, engineering analysis, and cadaveric evaluation were performed to demonstrate that the Exactech Equinoxe Humeral Augmented Trays perform as intended and are substantially equivalent to the identified predicate Equinoxe Humeral Adapter Trays previously cleared in K063569 and K082702:
- Fatigue strength testing under worst-case lateral loading
- Fatigue strength testing under worst-case medial loading ●
- Range of Motion Analysis ●
- Cadaveric evaluation
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Equinoxe Humeral Augmented Trays 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
Results of the non-clinical testing including mechanical testing, engineering analysis and cadaveric evaluation demonstrate the proposed Exactech Equinoxe Humeral Augmented Trays are substantially equivalent to the previously cleared Humeral Adapter Trays in the Exactech Equinoxe Reverse Shoulder System.