(63 days)
Not Found
No
The summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated to relieve pain and restore function in individuals with degenerative diseases of the glenohumeral joint, which directly addresses a health condition.
No
The device, Exactech Equinoxe™ Reverse Shoulder System, is an orthopedic implant designed to relieve pain and restore function in individuals with specific shoulder joint degenerative diseases or failed joint replacements. Its purpose is therapeutic, not diagnostic.
No
The device description clearly describes physical components (fracture adapter tray, humeral stems, screws) and their mechanical connections (morse taper, threads), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to relieve pain and restore function in individuals with degenerative diseases of the glenohumeral joint and a deficient rotator cuff, or failed glenohumeral joint replacement. This describes a surgical implant used for treatment, not a test performed on samples from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical implant component (fracture adapter tray, humeral stems, screws). This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Exactech Equinoxe™ Reverse Shoulder System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for 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, KWT
Device Description
The Equinoxe™ fracture adapter tray connects to the Equinoxe™ fracture humeral stems via a morse taper and a non-breakaway locking screw using a 5/16-18 thread instead of the primary adapter tray connecting to the primary/revision humeral stems via a spherical taper and a breakaway locking screw using a M6 thread
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
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)
Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure in profile, with three faces overlapping each other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Exactech, Incorporated Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K073688
Trade/Device Name: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Fracture Humeral Adapter Tray Locking Screw Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT Dated: January 31, 2008 Received: February 1, 2008
Dear Mr. Cuthbert:
This letter corrects our substantially equivalent letter of February 29, 2008.
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
1
(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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Summary of Exactech® Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Locking Screw Special 510(k) - Indications for Use
510(k) Number: K073688
Device Name: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Fracture Humeral Adapter Tray Locking Screw
INDICATIONS FOR USE:
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore ിറ്റ് Exation Equinox falled glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Prescription Use × and/or (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sabare Buchind forxym
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K073688
Section 5 Page 1 of 1
3
·
:
Summary of Exactech® Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Locking Screw Special 510(k) - 510(k) Summary
| Sponsor: | Exactech® Inc. |
|---|---|
| 2320 N.W. 66th Court | |
| Gainesville, Florida 32653 |
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671 ·
Graham Cuthbert Contact: Regulatory Representative
December 17, 2007 Date:
Section 9 Page 1 of 2
4
Summary of Exactech® Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Locking Screw Special 510(k) - 510(k) Summary
Trade or proprietary or model name(s):
Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Locking Screw
Common Name
Shoulder Joint Prosthesis
Classification name
Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650, Class II, Product Code KWT)
Prosthesis, Shoulder, Semi-constrained, metal/polymer cemented (21 CFR 888.3660, Class II, Product Code KWS)
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K063569 | Exactech EquinoxeTM Reverse Shoulder System | Exactech, Inc. |
Indications for Use:
The Exactech Equinoxe " Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Device Description:
The Equinoxe™ fracture adapter tray connects to the Equinoxe™ fracture humeral stems via a morse taper and a non-breakaway locking screw using a 5/16-18 thread instead of the primary adapter tray connecting to the primary/revision humeral stems via a spherical taper and a breakaway locking screw using a M6 thread
Substantial Equivalency Conclusion:
Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
Section 9 Page 2 of 2