(211 days)
No
The 510(k) summary describes a mechanical implant (shoulder system components) and the testing performed is mechanical testing. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is an arthroplasty system used to treat degenerative diseases or fractures of the glenohumeral joint, which involves treating a disease or injury.
No
The device description and intended use indicate that the Equinoxe Shoulder System is an orthopedic implant for treating degenerative diseases or fractures of the glenohumeral joint, not for diagnosing conditions.
No
The device description and performance studies clearly indicate this is a physical implant (glenoid components) and not a software-only device.
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 intervention performed directly on the patient's body.
- Device Description: The device is described as a shoulder system component (glenoid).
- Anatomical Site: The anatomical site is the glenohumeral joint and proximal humerus, which are parts of the human body.
- Performance Studies: The performance studies involve mechanical testing of the implant, not testing of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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:
| P | L | F | |
|---|---|---|---|
| √ | √ | 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 (comma separated list FDA assigned to the subject device)
KWS
Device Description
This submission proposes an increase in the angled surface from 12° to 16°, relative to the 12° posterior augment pegged glenoid devices previously cleared via 510(k) K111379. The proposed Exactech Equinoxe Posterior Augment Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, #K103419, and K111379.
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
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 testing per ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation was conducted to demonstrate the safety and effectiveness of the proposed posterior augment glenoids in support of the claim of substantial equivalence to the predicate device.
Cyclic Shear and Shear Load to Failure testing was conducted to demonstrate the safety and effectiveness of the proposed posterior augment glenoids in support of the claim of substantial equivalence to the predicate device
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.
K042021, K061454, K093430, K103419
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® UHMWPE 16° Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
NOV 2 0 2012
- Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617
I.
FDA Establishment Number 1038671
-
Graham L Cuthbert Contact: Regulatory Affairs Specialist II
Date: April 19, 2012 -
II. Proprietary Name: Exactech Equinoxe UHMWPE 16° Posterior Augment Pegged 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 |
|---|---|---|
| K111379 | Exactech Equinoxe UHMWPE 12 Degree | |
| Posterior Augment Pegged Glenoid | Exactech, Inc. |
IV. Device Description:
This submission proposes an increase in the angled surface from 12° to 16°, relative to the 12° posterior augment pegged glenoid devices previously cleared via 510(k) K111379. The proposed Exactech Equinoxe Posterior Augment Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, #K103419, and #K111379.
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® UHMWPE 16° Posterior Augment Pegged 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:
| 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 glevohumeral 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.
Rationale for Substantial Equivalence VI.
- Intended Use / Indications for Use. The proposed and predicate devices are ● intended for use in total shoulder joint replacement and have identical indications for use.
- Materials. The proposed and predicate devices are composed of identical ● biocompatible materials conforming to recognized industry standards for permanent implants.
2
Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness
- . Design Features. The proposed and predicate devices have the same design features. including articulating geometry and fixation.
- Dimensions. The proposed and predicate devices have identical geometry for mating . with previously cleared humeral stems and humeral heads. The only dimensional difference is an increase in the angled surface from 12° to 16°.
- Packaging and Sterilization. The proposed and predicate devices are packaged and ● sterilized using the same materials and processes.
- Device Shelf Life. The proposed and predicate devices have the same shelf life. .
VII. Summary of Non-Clinical Performance Data
Mechanical testing per ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation was conducted to demonstrate the safety and effectiveness of the proposed posterior augment glenoids in support of the claim of substantial equivalence to the predicate device.
Cyclic Shear and Shear Load to Failure testing was conducted to demonstrate the safety and effectiveness of the proposed posterior augment glenoids in support of the claim of substantial equivalence to the predicate device
Substantial Equivalence Conclusion
Test result and analyses provided in this 510(k) demonstrate the proposed Exactech Equinoxe Posterior Augment Glenoids are substantially equivalent to the cited predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a double helix, symbolizing health and life. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 20, 2012
Exactech, Incorporated % Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 Northwest 660 Court Gainesville, Florida 32653
Re: K121220
Trade/Device Name: Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™
Regulation Number: 21 CFR 888.3660
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: October 15, 2012 Received: October 22, 2012
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Graham L. Cuthbert
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin I.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use
K121220 510(k) Number:
Device Name: Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged 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 | |
|---|---|---|---|
| √ | √ | 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
6
Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use
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.
and/or Prescription Use X (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.11.20 08:49:28 -05'00'