(64 days)
Not Found
No
The summary describes a mechanical implant (shoulder system components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical and literature-based, not related to algorithmic performance.
Yes
Explanation: The device is an artificial shoulder joint replacement intended to treat degenerative diseases or fractures, which falls under the definition of a therapeutic device designed to restore function or mitigate disease.
No
The device is a shoulder implant system, and its intended use is to treat degenerative diseases or fractures of the glenohumeral joint through surgery (total or hemiarthroplasty). It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly indicates it is a physical humeral head component for a shoulder arthroplasty system, not a software-only device.
Based on the provided text, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the Equinoxe Shoulder System and its components (humeral stems, glenoids, humeral heads) are implants used in surgical procedures to replace or repair the glenohumeral joint. They are physical devices implanted into the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to perform any kind of test on a biological sample to diagnose a condition. Its purpose is therapeutic and reconstructive.
Therefore, the Equinoxe Shoulder System is a surgical implant, 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 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.
- 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 (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) | |
| √ | √ | √ | rotator cuff tear arthropathy |
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 (hemiarthroplasty), 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)
KWT, HSD
Device Description
The proposed Exactech Equinoxe CTA Humeral Head devices are humeral heads for use with the Equinoxe Shoulder System cleared via 510(k) K042021. Compared to predicate Equinoxe humeral heads, the proposed CTA Humeral Heads have an extended articular surface, designed to to contact the acromion in a rotator-cuff deficient patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, proximal humerus, mid-humerus
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)
Literature reviews, mechanical tests, simulated-use tests, and engineering analyses demonstrate the proposed Equinoxe CTA Humeral Head devices are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- . Cadaver and sawbones lab validation demonstrating the design features.
- Mechanical testing to verify CTA Humeral Head structural integrity and fixation . properties.
- . Clinical literature reviews of CTA devices and clinical failure modes.
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.
K042021, K000575, K082715, K030710, K042321
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
§ 888.3650 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
Exactech® Equinoxe® CTA Humeral Head Traditional 510(k) - 510(k) Summary
| I. | Submitter Information
Company: | Exactech, Inc | MAY 17 2011 |
|-----|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | Date: | March 11th, 2011 | |
| | Contact Person: | Graham L. Cuthbert
Regulatory Affairs Specialist II
Telephone: (352) 327-4613
Fax: (352) 378-2617 | |
| II. | Device Information
Proprietary Name: | Exactech® Equinoxe® Cuff Tear Arthroplasty (CTA) Head | |
| | Common Name: | Humeral Component | |
| | Classification Name: | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
Cemented (21 CFR 888.3650, Class II, Product Code
KWT)
Prosthesis, Shoulder, Hemi-, Humeral, Metallic
Uncemented (21 CFR 888.3660, Class II, Product Code
HSD) | |
III. Legally Marketed Devices to Which Substantial Equivalence Is Claimed
- Exactech Equinoxe, K042021 ●
- DePuy Global Advantage Extended Humeral Head, K000575 & K082715 .
- Biomet Bio-Modular EAS Head, K030710 & K042321 .
IV. Device Description
The proposed Exactech Equinoxe CTA Humeral Head devices are humeral heads for use with the Equinoxe Shoulder System cleared via 510(k) K042021. Compared to predicate Equinoxe humeral heads, the proposed CTA Humeral Heads have an extended articular surface, designed to to contact the acromion in a rotator-cuff deficient patient.
V. 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 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.
- 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.
1
Exactech® Equinoxe® CTA Humeral Head Traditional 510(k) - 510(k) Summary
Clinical indications for the PRIMARY (P), LONG (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) | |||
| √ | √ | √ | rotator cuff tear arthropathy |
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 (hemiarthroplasty), 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.
VI. Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
2
(3/3)
Exactech® Equinoxe® CTA Humeral Head Traditional 510(k) - 510(k) Summary
- Intended Use. The Equinoxe CTA Humeral Head devices and predicate devices . are intended for use in shoulder joint replacement and have similar indications for use statements.
- Materials. The Equinoxe CTA Humeral Head devices and predicate devices are . composed of equivalent materials conforming to recognized industry standards for permanent implants.
- Dimensions. The Equinoxe CTA Humeral Head devices and predicate device . components are available in equivalent size ranges.
- . Sterilization processes. The Equinoxe CTA Humeral Head devices and predicate devices are sterilized using equivalent sterilization processes conforming to recognized industry standards.
- . Performance specifications. The Equinoxe CTA Humeral Head devices and predicate devices conform to recognized performance standards for total shoulder joint replacement.
Substantial Equivalence Conclusion
Literature reviews, mechanical tests, simulated-use tests, and engineering analyses demonstrate the proposed Equinoxe CTA Humeral Head devices are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- . Cadaver and sawbones lab validation demonstrating the design features.
- Mechanical testing to verify CTA Humeral Head structural integrity and fixation . properties.
- . Clinical literature reviews of CTA devices and clinical failure modes.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exactech, Inc. % Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
MAY 17 2011
Re: K110706
Trade/Device Name: Exactech Equinoxe Cuff Tear Arthropathy (CTA) Humeral Head Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT. HSD Dated: March 11, 2011 Received: March 14, 2011
Dear Mr. Cuthbert:
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
4
Page 2 - Mr. Graham Cuthbert
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 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, !nternational 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 yours,
Aty 13.12.h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
_ KII0706 510(k) Number:
Device Name:
Exactech Equinoxe® CTA Humeral Head
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 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.
- � 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 (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) | |
| √ | √ | √ | rotator cuff tear arthropathy |
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
(continued on next page)
6
gienohumeral 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.
| Prescription Use X
| And Concession American American American Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of C | and/or | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
for m.Melkern
(Division $igm Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110706