(30 days)
No
The summary describes a mechanical implant (shoulder system) and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical properties.
Yes
The device, a Shoulder System, is indicated for treating degenerative diseases or fractures of the glenohumeral joint, which are medical conditions, making it a therapeutic device.
No
The device is a shoulder implant system intended for treating degenerative diseases or fractures of the glenohumeral joint through arthroplasty, which is a therapeutic rather than a diagnostic function.
No
The device description and intended use clearly describe physical implants (humeral stems, glenoids, humeral heads) used in shoulder arthroplasty, not software.
Based on the provided text, 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 description clearly states that the Equinoxe Shoulder System is a surgical implant used for treating degenerative diseases or fractures of the glenohumeral joint. It is a physical device implanted into the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
- Focus on Surgical Treatment: The entire document focuses on the surgical implantation and function of the shoulder prosthesis.
Therefore, the Equinoxe Shoulder System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used with . bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications or in . revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
- 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 fixation can be achieved)
- Displaced three-part and four-part upper humeral fractures
- Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
- Revision of failed previous reconstructions when distal anchorage is required
- To restore mobility from previous procedures (e.g. previous fusion)
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.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
This submission proposes modifying Exactech Equinoxe Cage Glenoid devices cleared via 510(k) #K093430 to change peg geometry and add plasma coating. The proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021 and 510(k) #K061454 as cited predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glenohumeral joint, proximal humerus
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Surgeon, Orthopaedic surgeon
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)
- Mechanical glenoid loosening/disassociation testing per ASTM F2028 .
- Mechanical testing for axial disassembly of modular pegs .
- Mechanical testing for resistance of locking mechanism to shear and bending .
- Plasma coating shear fatigue strength testing per ASTM F1160 .
- Plasma coating static shear strength testing per ASTM F1044 .
- Plasma coating static tensile strength testing per ASTM F1147 .
- Plasma coating abrasion testing per ASTM F1978
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
Exactech Equinoxe® Cage Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
-
Exactech® Inc. I. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671 -
Contact: Patrick Hughes Regulatory Affairs Specialist
Date: November 28, 2011
II. Proprietary Name: Exactech Equinoxe Cage Glenoids
Common Name:
Glenoid Component
Classification Name:
Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660, Class II, Product Code: KWS)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K093430 | Exactech Equinoxe Cage Glenoid | Exactech, Inc. |
Device Description: IV.
This submission proposes modifying Exactech Equinoxe Cage Glenoid devices cleared via 510(k) #K093430 to change peg geometry and add plasma coating. The proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021 and 510(k) #K061454 as cited predicates.
V. Intended Use of the Device
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems, and all . Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used with . bone cement at the discretion the surgeon.
1
Exactech Equinoxe® Cage Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
- The reverse humeral components are intended to be used in cemented applications or in . revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | 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 fixation can be achieved) | |
| √ | Displaced three-part and four-part upper humeral fractures | ||
| √ | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | ||
| √ | Revision of failed previous reconstructions when distal anchorage is required | ||
| √ | √ | To restore mobility from previous procedures (e.g. previous fusion) |
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.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
2
Exactech Equinoxe® Cage Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
VI. Rationale for Substantial Equivalence
Intended Use / Indications for Use. Both proposed and predicate devices have identical indications for use.
Materials. Both proposed and predicate devices are composed of identical biocompatible materials conforming to recognized industry standards for permanent implants. The only material difference is the addition of cp-titanium plasma coating on the central peg of the proposed devices.
Design Features. Both proposed and predicate devices have the same key design features, including articulating geometry and fixation.
Dimensions. Both proposed and predicate devices have identical geometry for mating with the same Equinoxe humeral stems and heads. The only dimensional difference is a change to the length and diameter of the glenoid pegs and associated locking mechanisms of the proposed devices.
Packaging and Sterilization. Both proposed and predicate devices are packaged and sterilized using the same materials and processes.
Device Shelf Life. Proposed and predicate devices have the same shelf life.
Fixation Method: Proposed and predicate devices use the same cemented-only fixation method, where bone cement is applied to cover the entire back of the glenoid component and the peg, keel, and cage, and cage augment features are also fully cemented.
VII. Summary of Non-Clinical Performance Data
- Mechanical glenoid loosening/disassociation testing per ASTM F2028 .
- Mechanical testing for axial disassembly of modular pegs .
- Mechanical testing for resistance of locking mechanism to shear and bending .
- Plasma coating shear fatigue strength testing per ASTM F1160 .
- Plasma coating static shear strength testing per ASTM F1044 .
- Plasma coating static tensile strength testing per ASTM F1147 .
- Plasma coating abrasion testing per ASTM F1978 ●
Substantial Equivalence Conclusion VIII.
Test results and analyses provided in this submission demonstrate the proposed Equinoxe Cage Glenoids are substantially equivalent to the cited predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wavy lines representing the snakes and staff. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Exactech, Inc. % Mr. Patrick Hughes Regulatory Affairs Specialist 2320 Northwest 660 Court Gainesville, Florida 32605
DEC - 8 2011
Re: K113309
Trade/Device Name: Exactech Equinoxe Cage Glenoids Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: November 7, 2011 Received: November 8, 2011
Dear Mr. Hughes:
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. Ilsting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Patrick Hughes
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 y
Mark N. N Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech Equinoxe® Cage GlenoidsTM Special 510(k) - Indications for Use
113309
510(k) Number:
Device Name: Exactech Equinoxe Cage Glenoids
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be used with . bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications or in . revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- Humeral heads are intended for use in cemented and press-fit applications. .
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | 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 fixation can be achieved) | |
| √ | Displaced three-part and four-part upper humeral fractures | ||
| √ | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | ||
| √ | Revision of failed previous reconstructions when distal anchorage is required | ||
| √ | √ | To restore mobility from previous procedures (e.g. previous fusion) |
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.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient,
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113309
Exactech Equinoxe® Cage Glenoids™ Special 510(k) - Indications for Use
irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
of 2
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Alves for mvm
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113309