(220 days)
No
The summary describes a mechanical implant with dimensional modifications, and the performance studies are based on mechanical testing and geometric analysis, not AI/ML algorithms.
Yes
The device is indicated for use in individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff, or for failed glenohumeral joint replacement, which are conditions that require therapeutic intervention.
No
The device is a reverse shoulder system intended for surgical implantation to treat degenerative diseases of the glenohumeral joint. It does not perform any diagnostic function.
No
The device description clearly details physical components (glenosphere, humeral liners, glenoid baseplate, locking screw) and the performance studies involve mechanical tests and simulated surgical implantations, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating degenerative diseases and failed joint replacements in the shoulder. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a shoulder implant (glenosphere and humeral liners) and their function in a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical properties, stability, and range of motion of the implant, which are relevant to a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
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
PHX, KWS, KWS, KWT
Device Description
Glenosphere
The proposed Equinoxe Reverse Shoulder System 36mm Glenosphere is a modification to the existing Equinoxe Reverse Shoulder System glenospheres previously cleared in K063569. The 36mm Glenosphere mates with previously cleared Equinoxe Reverse Shoulder glenoid baseplate and the glenosphere locking screw (K063569). The rationale for the modification of the devices is to offer a smaller glenosphere for patients in whom the 38mm glenosphere is too large.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- · The same indications for use
- · The same design features
- · Incorporate the same materials
- · The same shelf life
- · Are packaged and sterilized using the same materials and processes.
The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the glenosphere to 36mm, as well as the removal of the extractor cavities on the side of the glenosphere due to size limitations.
Humeral Liners
The proposed Equinoxe Reverse Shoulder System 36mm Humeral Liners are a modification to the existing Equinoxe Reverse Shoulder System humeral liners previously cleared in K063569. The 36mm Humeral Liners mate with previously cleared Equinoxe Reverse Shoulder humeral tray (K063569). The rationale for the modification of the devices is to offer a smaller humeral liner for patients in whom the 38mm humeral liner is too large.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· The same indications for use
- · The same design features
- · Incorporate the same materials
- · The same shelf life
- · Are packaged and sterilized using the same materials and processes.
The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the humeral liners to 36mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint
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: Mechanical tests, engineering analyses, and simulated surgical (sawbones) implantations
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- A Finite Element Analysis of 36mm Equinoxe Glenosphere which simulated the worstcase loading condition and demonstrated the stresses on the device were below the ASTM yield strength.
- A dynamic loading study in which the stability of the Equinoxe 36mm glenosphere and liners was assessed in a polyurethane bone substitute. The study demonstrated that the proposed devices performed as intended at varying degrees of adduction.
- A geometric analysis evaluating the jump distance between the proposed Equinoxe . 36mm glenospheres and liners and their predicates demonstrated the devices are expected to provide similar relative stability and range of motion.
- A polyurethane bone substitute validation was performed to assess passive range of . motion for the proposed devices. Proper articulation was achieved during this validation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of three human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Exactech, Incorporated Ms. Lindy Knisely Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K093275
Trade/Device Name: Exactech Equinoxe® Reverse Shoulder System 36 mm Glenosphere and Humeral Liners 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: April 26, 2010 Received: April 29, 2010
Dear Ms. Knisely:
This letter corrects our substantially equivalent letter of May 27, 2010.
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
1
Page 2 - Ms. Lindy Kniselv
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/ResourcesforYou/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
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Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners Special 510(k) - Indications for Use (DRAFT)
Indications for Use Statement
510(k) Number:
Device Name: Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liner
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.
Prescription Use X 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)
Smetu 3 for mxn
(Division Sign)m
vision Sien ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093275
3
Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
MAY 2 7 2010
. . .
510(k) Summary of Safety and Effectiveness
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
- Lindy Knisely, RN Contact: Regulatory Affairs Specialist
May 26, 2010 Date:
Trade or Proprietary or Model Name(s):
Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere Exactech Equinoxe Reverse Shoulder System 36mm Unconstrained Humeral Liner (+0mm) Exactech Equinoxe Reverse Shoulder System 36mm Unconstrained Humeral Liner (+2.5mm) Exactech Equinoxe Reverse Shoulder System 36mm Constrained Humeral Liner (+0mm) Exactech Equinoxe Reverse Shoulder System 36mm Constrained Humeral Liner (+2.5mm)
Common Name: Reverse Shoulder 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 | Equinoxe Reverse Shoulder System | Exactech, Inc. |
| Indications for Use: |
4
Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
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.
Device Description:
Glenosphere
The proposed Equinoxe Reverse Shoulder System 36mm Glenosphere is a modification to the existing Equinoxe Reverse Shoulder System glenospheres previously cleared in K063569. The 36mm Glenosphere mates with previously cleared Equinoxe Reverse Shoulder glenoid baseplate and the glenosphere locking screw (K063569). The rationale for the modification of the devices is to offer a smaller glenosphere for patients in whom the 38mm glenosphere is too large.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- · The same indications for use
- · The same design features
- · Incorporate the same materials
- · The same shelf life
- · Are packaged and sterilized using the same materials and processes.
The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the glenosphere to 36mm, as well as the removal of the extractor cavities on the side of the glenosphere due to size limitations.
Humeral Liners
The proposed Equinoxe Reverse Shoulder System 36mm Humeral Liners are a modification to the existing Equinoxe Reverse Shoulder System humeral liners previously cleared in K063569. The 36mm Humeral Liners mate with previously cleared Equinoxe Reverse Shoulder humeral tray (K063569). The rationale for the modification of the devices is to offer a smaller humeral liner for patients in whom the 38mm humeral liner is too large.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· The same indications for use
5
Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
- · The same design features
- · Incorporate the same materials
- · The same shelf life
- · Are packaged and sterilized using the same materials and processes.
The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the humeral liners to 36mm.
Substantial Equivalence of Non-Clinical Performance Data:
Mechanical tests, engineering analyses, and simulated surgical (sawbones) implantations were conducted to demonstrate substantial equivalence to the predicate devices listed above. A summary of these tests and analyses are as follows:
- . A Finite Element Analysis of 36mm Equinoxe Glenosphere which simulated the worstcase loading condition and demonstrated the stresses on the device were below the ASTM yield strength.
- . A dynamic loading study in which the stability of the Equinoxe 36mm glenosphere and liners was assessed in a polyurethane bone substitute. The study demonstrated that the proposed devices performed as intended at varying degrees of adduction.
- A geometric analysis evaluating the jump distance between the proposed Equinoxe . 36mm glenospheres and liners and their predicates demonstrated the devices are expected to provide similar relative stability and range of motion.
- A polyurethane bone substitute validation was performed to assess passive range of . motion for the proposed devices. Proper articulation was achieved during this validation.
Substantial Equivalence Conclusion:
Results of mechanical test and engineering analysis referenced in this 510(k) submission demonstrate that the Exactech Equinoxe 36mm Glenosphere and Humeral Liners are substantially equivalent to the cleared predicate devices.