(107 days)
No
The summary describes a modular mechanical prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a prosthesis intended for use in shoulder arthroplasty to treat various medical conditions, indicating a therapeutic purpose.
No
The device is a prosthesis intended for surgical replacement of parts of the humerus, not for diagnosing conditions.
No
The device description clearly outlines a physical prosthesis made of Ti-6A1-4V with various components (proximal bodies, middle segments, distal stems, distal fixation rings) intended for surgical implantation. This is a hardware medical device, not software.
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 taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Equinoxe Mega Prosthesis System is a surgical implant designed to replace parts of the humerus (upper arm bone) in the shoulder joint. It is used in the body during surgery, not to test samples from the body.
- Lack of IVD Characteristics: The description focuses on the physical components, materials, and surgical application of the prosthesis. There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, the Equinoxe Mega Prosthesis System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Revision where other devices or treatments have failed
- · Correction of functional deformity
- Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- · Traumatic arthritis
- · Oncology applications including bone loss due to tumor resection.
- · Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.
The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.
Product codes
KWT, KWS, PHX, HSD
Device Description
The Equinoxe Mega Prosthesis differs from conventional Total Shoulder Arthroplasty implants in that it is intended to replace both the articulating surface (humeral head) as well as the resected humerus. The modular design allows for the surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone, and to maintain the patient's natural arm length.
The prosthesis is manufactured from Ti-6A1-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in four sizes (Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter (20mm). The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal fixation rings are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal fixation rings are intended for press-fit fixation. The proximal bodies and middle segments have suture through holes to facilitate soft tissue attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical setting
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 clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Mega Prosthesis performs as intended and is substantially equivalent to the identified predicate device:
- Clinical Literature Review
- Cadaveric Study
- Plasma Spray Coating Characterization
- Fatigue Testing
- Torsion Testing
- Taper Analysis
- Axial Pull-Off Testing
- Suture Abrasion Testing
Bench testing was conducted to address the design differences between the proposed Exactech Equinoxe Mega Prosthesis and the identified predicate device, including the use of a distal fixation ring and different sizes of distal stems and proximal bodies, as well as the addition of the indication for reverse shoulder arthroplasty.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Biomet Comprehensive Segmental Revision System (K111746)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Exactech, Incorporated Mr. Thomas McNamara Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K143659
Trade/Device Name: Exactech® Equinoxe® Mega Prosthesis Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Class: Class II Product Code: KWT, KWS, PHX, HSD Dated: January 8, 2015 Received: January 12, 2015
Dear Mr. McNamara:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143659
Device Name
Exactech® Equinoxe® Mega Prosthesis
Indications for Use (Describe)
The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Revision where other devices or treatments have failed
- · Correction of functional deformity
- Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- · Traumatic arthritis
- · Oncology applications including bone loss due to tumor resection.
- · Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.
The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.
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) |
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3
Exactech® Equinoxe® Mega Prosthesis Traditional 510(k) - 510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 8, 2015 |
| Contact Person: | Thomas McNamara
Regulatory Affairs Specialist
Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Equinoxe® Mega Prosthesis |
| Common Name: | Humeral Stem |
| Classification Name: | Prosthesis, Shoulder, Non-Constrained, Meta/Polymer
Cemented, (21 CFR Section 888.3650, Class II, Product
Code KWT), Prosthesis, Shoulder, Semi-Constrained
cemented prosthesis (21 CFR Section 888.3660, Class II
Product Code KWS), Shoulder Prosthesis, Reverse
Configuration (21 CFR Section 888.3660, Class II Product
Code PHX) Prosthesis, Shoulder, Hemi-, Humeral Metallic
Uncemented, (21 CFR Section 888.3690, Class II, Product
Code HSD) |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- Biomet Comprehensive Segmental Revision System (K111746) ●
Device Description
The Equinoxe Mega Prosthesis differs from conventional Total Shoulder Arthroplasty implants in that it is intended to replace both the articulating surface (humeral head) as well as the resected humerus. The modular design allows for the surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone, and to maintain the patient's natural arm length.
The prosthesis is manufactured from Ti-6A1-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in four sizes (Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter (20mm). The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal fixation rings are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal fixation rings are intended for press-fit fixation. The proximal bodies and middle segments have suture through holes to facilitate soft tissue attachment.
4
Indications for Use
The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- . Rheumatoid arthritis
- . Revision where other devices or treatments have failed
- Correction of functional deformity
- . Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- . Traumatic arthritis
- . Oncology applications including bone loss due to tumor resection.
- . Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.
The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, pressfit use.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- Indications for Use. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device have similar indications for use. The proposed Exactech Equinoxe Mega Prosthesis is also indicated for use in hemi-shoulder arthroplasty and reverse shoulder arthoplasty. In cases with significant proximal humeral resections, joint stability is the primary concern. The stability of the joint is comparable for hemi and total shoulder indications, because stability is achieved by dynamic muscle balancing. The stability of the joint in a reverse shoulder is achieved via the inverted articular concavities without any requirement for dynamic stability provided by the rotator cuff. The additions of the proposed hemi
5
Exactech® Equinoxe® Mega Prosthesis Traditional 510(k) - 510(k) Summary
and reverse shoulder arthroplasty indications do not create a new intended use for the proposed device.
- Materials/Surface Finish/Coatings. The proposed Exactech Equinoxe Mega . Prosthesis and the predicate device are composed of similar, biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
- . Design Features. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device share similar design features. Design differences between the cited predicate device and the propose Exactech Equinoxe Mega Prosthesis include the use of a distal fixation ring and different sizes of distal stems and proximal bodies, as well as the hemi- and reverse shoulder indications.
- Dimensions. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device are dimensionally comparable.
- Sterilization. The proposed Exactech Equinoxe Mega Prosthesis and the . predicate device are provided sterile for single use only.
- Performance Requirements. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device conform to recognized performance standards for shoulder replacement devices.
Non-Clinical Testing
The following clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Mega Prosthesis performs as intended and is substantially equivalent to the identified predicate device:
- Clinical Literature Review ●
- Cadaveric Study ●
- Plasma Spray Coating Characterization ●
- Fatigue Testing
- . Torsion Testing
- Taper Analysis
- Axial Pull-Off Testing ●
- . Suture Abrasion Testing
Bench testing was conducted to address the design differences between the proposed Exactech Equinoxe Mega Prosthesis and the identified predicate device, including the use of a distal fixation ring and different sizes of distal stems and proximal bodies, as well as the addition of the indication for reverse shoulder arthroplasty.
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of combined mechanical testing, cadaveric validation study, and clinical literature review described above, it was concluded that Exactech Equinoxe Mega Prosthesis demonstrates substantial equivalence to the referenced predicate device.