(135 days)
Not Found
No
The summary describes a mechanical implant system with minor geometry changes and provides performance data from non-clinical testing of mechanical properties. There is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
Yes
The device is indicated for degenerative diseases of the glenohumeral joint and failed glenohumeral joint replacement, which are medical conditions, and its purpose is reverse shoulder arthroplasty, which is a therapeutic intervention.
No
Explanation: The device is a reverse shoulder system used for joint replacement, not for diagnosing medical conditions. The "Intended Use" clearly states it's for "use in skeletally mature individuals with degenerative diseases of the glenohumeral joint" and "a failed glenohumeral joint replacement," which describes a treatment, not a diagnostic purpose.
No
The device description explicitly states it is a "reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation," which are all hardware components. The performance studies also describe testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant system (Equinoxe Reverse Shoulder System) used to replace a damaged shoulder joint. It consists of components like glenoid plates, glenospheres, screws, and humeral liners.
- Intended Use: The intended use is for surgical implantation in skeletally mature individuals with specific shoulder conditions.
- No Mention of Samples or Testing: The description and intended use do not involve the analysis of samples taken from the body for diagnostic purposes.
This device is a surgical implant used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWS, KWT
Device Description
The Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.
Both the proposed and predicate devices share the following similarities:
- The same Indications for Use
- . The same intended use
- The same materials
- . The same design features and basic fundamental scientific technology
- The same compression screws. glenosphere locking screw. humeral liners. . humeral adapter trays, and humeral stem compatibility
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech Equinoxe Small Reverse Shoulder System performs as intended and is substantially equivalent to the identified predicate devices:
- Equinoxe Small Glenoid Plate Fixation Testing in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Equinoxe Small Glenoid Plate/ Glenosphere Fixation Testing in accordance . with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Range of Motion Evaluation of the Equinoxe Small Reverse Shoulder ● Implants in accordance with ASTM F1378
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Equinoxe Small Reverse 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.
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Equinoxe Small Reverse Shoulder System devices are substantially equivalent to the cited cleared predicate Equinoxe 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.
K063569, K110708, K093275, K102951, K131575
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.
Not Found
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
July 25, 2018
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
Exactech, Inc. Zach Sharrah Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K180632
Trade/Device Name: Exactech® Equinoxe® Small Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWS, KWT Dated: June 21, 2018 Received: June 25, 2018
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. 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
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 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,
Peter G. Allen -S 2018.07.25 11:15:28 -04'00'
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K180632
Device Name
Exactech® Equinoxe® Small Reverse Shoulder System
Indications for Use (Describe)
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
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® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech®, Inc.
2320 NW 66th Court
Gainesville FL, 32653 |
|-------------------|---------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact Person: | Zach Sharrah
Regulatory Affairs Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Date: | March 5, 2018 |
| Proprietary Name: | Exactech® Equinoxe® Small Reverse Shoulder System |
| Common Name: | Reverse Shoulder Arthroplasty |
Classification Name:
- . Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, Class II, Product Code PHX
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3660, Class II, Product Code KWS
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3650, Class II, Product Code KWT
| Legally Marketed Device to Which Substantial Equivalence Is Claimed: | ||||
|---|---|---|---|---|
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Equinoxe Reverse Shoulder System | Exactech, Inc. | K063569 |
| Equinoxe Reverse Shoulder Line Extensions | Exactech, Inc. | K110708 |
| Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners | Exactech, Inc. | K093275 |
| Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenosphere | Exactech, Inc. | K102951 |
| Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate | Exactech, Inc. | K131575 |
Indications for Use:
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
4
Exactech® Equinoxe® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
The Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.
Both the proposed and predicate devices share the following similarities:
- The same Indications for Use ●
- . The same intended use
- The same materials
- . The same design features and basic fundamental scientific technology
- The same compression screws. glenosphere locking screw. humeral liners. . humeral adapter trays, and humeral stem compatibility
Non-Clinical Testing:
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech Equinoxe Small Reverse Shoulder System performs as intended and is substantially equivalent to the identified predicate devices:
- Equinoxe Small Glenoid Plate Fixation Testing in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Equinoxe Small Glenoid Plate/ Glenosphere Fixation Testing in accordance . with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Range of Motion Evaluation of the Equinoxe Small Reverse Shoulder ● Implants in accordance with ASTM F1378
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Equinoxe Small Reverse 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:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Equinoxe Small Reverse Shoulder System devices are substantially equivalent to the cited cleared predicate Equinoxe devices.