(21 days)
No
The summary describes a mechanical implant (shoulder system) and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing.
Yes
The device is a shoulder prosthesis used to treat degenerative diseases or fractures of the glenohumeral joint, aiming to restore joint function and alleviate symptoms.
No
Explanation: The device is an orthopedic implant (shoulder system components) used for treatment (arthroplasty) of degenerative diseases or fractures, not for diagnosing them. Its intended use describes treatment, not detection or identification of a disease or condition.
No
The device description and intended use clearly describe physical implants (shoulder system components, glenoids, stems, humeral heads) used in surgical procedures, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating degenerative diseases and fractures of the glenohumeral joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a shoulder system component (glenoid) made of UHMWPE, intended for surgical implantation.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, tissue, etc.) or provide information for diagnosis.
- Performance Studies: The performance studies mentioned are mechanical tests related to the physical properties and stability of the implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
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 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/R) and FRACTURE (F) : humeral components are as follows:
| P | L/R | 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, 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
KWS
Device Description
The proposed Equinoxe UHMWPE Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, and #K093430. Equinoxe UHMWPE posterior augment glenoids combine materials and features found in the cited predicates. The proposed Equinoxe UHMWPE posterior augment glenoids are manufactured from the same materials as glenoid components cleared via #K042021 and #K093430, and feature the same articulating and angled geometry as glenoid components cleared via #K093430.
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 .
- . similar design features
- the same shelf life .
- . are packaged and sterilized using the same materials and processes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, mid-humerus, 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)
Results of mechanical testing referenced in this submission shows the proposed devices meet requirements specified in ASTM F2028, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation and demonstrate the proposed Equinoxe UHMWPE Posterior Augment Pegged Glenoids are substantially equivalent to cited cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K103419 (1/3)
SS & E
Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech® Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 | DEC 1 3 2010 |
|----------|-----------------------------------------------------------------|--------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 | |
| | FDA Establishment Number 1038671 | |
- Contact: Patrick Hughes Regulatory Affairs Specialist
- Date: November 19, 2010
Trade or Proprietary or Model Name(s):
Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™
Common Name:
Glenoid Component
Classification Name:
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 |
|---|---|---|
| K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc |
| K093430 | Exactech Equinoxe Cage Glenoid, XL Keeled, & | |
| XL Pegged Glenoid | Exactech, Inc. |
Purpose of Submission:
The modifications proposed by this submission include combining:
- the same articulating geometry and angled/augmented surface as Exactech Equinoxe . Cage Glenoid, XL Keeled & XL Pegged Glenoid devices cleared via 510(k) K093430
- the same ultra high molecular weight polyethylene (UHMWPE) material and fixation . features as Exactech Equinoxe Shoulder System devices cleared via 510(k) K042021
1
Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
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 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/R) and FRACTURE (F) : humeral components are as follows:
| P | L/R | 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, 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® UHMWPE Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
The proposed Equinoxe UHMWPE Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, and #K093430. Equinoxe UHMWPE posterior augment glenoids combine materials and features found in the cited predicates. The proposed Equinoxe UHMWPE posterior augment glenoids are manufactured from the same materials as glenoid components cleared via #K042021 and #K093430, and feature the same articulating and angled geometry as glenoid components cleared via #K093430.
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 .
- . similar design features
- the same shelf life .
- . are packaged and sterilized using the same materials and processes
Substantial Equivalence Conclusion:
Results of mechanical testing referenced in this submission shows the proposed devices meet requirements specified in ASTM F2028, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation and demonstrate the proposed Equinoxe UHMWPE Posterior Augment Pegged Glenoids are substantially equivalent to cited cleared predicate devices.
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 the HHS logo, which consists of a stylized caduceus symbol, representing health and medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
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 66th Court Gainesville, Florida 32653
DEC 1 3 2010
Re: K103419
Trade/Device Name: Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™
Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: November 19, 2010 Received: November 22, 2010
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, 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. Patrick Hughes
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/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 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 yours,
Az. B. nte
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use
K103419 510(k) Number:
DEC 1 3 2010
Device Name: Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™
1112
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/R) 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 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, 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.
6
K103419 (2/2)
TCU
Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use
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)
(Division Sign-Off)
for M. Melkerm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102419