(266 days)
No
The document describes a mechanical shoulder implant system and its indications for use. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is an orthopedic implant (shoulder system) used to treat degenerative diseases or fractures of the glenohumeral joint, which directly addresses a health condition.
No
This device is a shoulder implant system, designed for treatment of degenerative diseases or fractures of the glenohumeral joint. It is a therapeutic device, not a diagnostic one.
No
The device description and intended use clearly describe a physical implantable medical device (shoulder system components) and 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the Equinoxe Shoulder System as a device intended for surgical implantation to treat degenerative diseases or fractures of the glenohumeral joint. It involves replacing or reconstructing parts of the shoulder joint.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
The device is a surgical implant, not a diagnostic tool.
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 | Indications |
|---|---|---|---|
| √ | √ | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | |
| √ | √ | Congenital abnormalities in the skeletally mature | |
| √ | Primary and secondary necrosis of the humeral head. | ||
| √ | √ | Humeral head fracture with displacement of the tuberosities | |
| √ | √ | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | |
| √ | √ | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | |
| √ Displaced three-part and four-part upper humeral fractures | |||
| √ | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | ||
| √ | √ | Revision of failed previous reconstructions when distal anchorage is required | |
| √ | √ | To restore mobility from previous procedures (e.g. previous fusion) |
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Product codes
PHX, KWS, KWT
Device Description
The proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.
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
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)
Non-clinical testing was performed for: Humeral Liner Wear, Range of Motion, Scapular Notching, Humeral Adapter Tray/Humeral Stem Fatigue, Humeral Stem Fatigue, Humeral Liner/Humeral Adapter Tray Fatigue, Humeral Liner Lever Out, Humeral Liner Pull Out, Humeral Liner Torque-Out, Biocompatibility, Bacterial endotoxins (LAL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063569, K082702, K093275, K180632, K182536
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 14, 2023
Exactech, Inc Liz Howell Senior Regulatory Affairs Specialist 2320 NW 66th CT Gainesville, Florida 32653
Re: K223833
Trade/Device Name: Exactech® Equinoxe® Humeral Liners and Humeral Adapter Travs Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT Dated: August 14, 2023 Received: August 14, 2023
Dear Liz Howell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Farzana
Sharmin -S
Digitally signed by Farzana Sharmin
-S
Date: 2023.09.14 09:18:01 -04'00'
Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223833 Device Name
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
Indications for Use (Describe)
The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.
- The cemented primary humeral stem, longrevision 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 surgeon.
- . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
- . Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | |
| √ | √ | Congenital abnormalities in the skeletally mature | |
| √ | Primary and secondary necrosis of the humeral head. | ||
| √ | √ | Humeral head fracture with displacement of the tuberosities | |
| √ | √ | Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable | |
| √ | √ | Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) | |
| √ | Displaced three-part and four-part upper humeral fractures | ||
| √ | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) | ||
| √ | √ | Revision of failed previous reconstructions when distal anchorage is required | |
| √ | √ | To restore mobility from previous procedures (e.g. previous fusion) |
The Equinoxe Reverse Shoulder System is 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 in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), 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 proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays Traditional 510(k) - 510(k) Summary
| Company | Exactech, Inc.
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Liz Howell
Senior Regulatory Affairs Specialist
Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Date | 22 December 2022 |
| Proprietary Name | Exactech® Equinoxe® Reverse Humeral Liners and
Humeral Adapter Trays |
| Common Name | Shoulder prosthesis, humeral components |
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented
prosthesis (Class II per 21 CFR §888.3660)
Shoulder joint metal/polymer non-constrained cemented
prosthesis (Class II per 21 CFR §888.3650) |
| Product Code | PHX, KWS, KWT |
| Classification Panel | Orthopedic |
DEVICE DESCRIPTION
The proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.
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 | Indications |
|---|---|---|---|
| √ | √ | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems | |
| √ | √ | Congenital abnormalities in the skeletally mature | |
| √ | Primary and secondary necrosis of the humeral head. |
5
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays Traditional 510(k) - 510(k) Summarv
| √ | √ | 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.
TECHNOLOGICAL CHARACTERISTICS
Compared to the predicate devices, the proposed Humeral Liners have additional material on the locking feature. The proposed Humeral Liners are provided in two varying angles to accommodate for a 135-degree and 145-degree humeral neck angle with the 135-degree Humeral Liners representing a new variant. Compared to the predicate devices containing a "neck-down" feature, the proposed Humeral Trays have a uniform outer diameter. The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- Indications for Use. The proposed Reverse Humeral Liners and Humeral Adapter . Trays and the predicate devices have identical indications for use.
- Materials. The proposed Reverse Humeral Liners and Humeral Adapter Trays and the . predicate devices are composed of identical biocompatible materials.
- Design Features. The proposed Reverse Humeral Liners and Humeral Adapter Trays ● and the predicate devices have similar design features.
- Dimensions. The proposed Reverse Humeral Liners and Humeral Adapter Trays and the predicate devices are dimensionally comparable.
- Sterilization. The proposed Reverse Humeral Liners and Humeral Adapter Trays and . the predicate devices are provided sterile for single use only.
6
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays Traditional 510(k) - 510(k) Summary
- Performance Requirements. The proposed Reverse Humeral Liners and Humeral . Adapter Trays and the predicate devices conform to the same recognized performance standards.
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
| 510k Number(s) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| Primary Predicate | ||
| K063569, K082702, K093275, K180632, K182536 | Equinoxe Reverse Shoulder System | Exactech, Inc. |
| Additional Predicate | ||
| K193394 | Humeral Cup Stability & Humeral Cup 135/145° Stability | FX Shoulder USA |
NON-CLINICAL TESTING
The proposed Equinoxe Reverse Humeral Liners and Humeral Adapter Trays have been evaluated for the following:
- . Humeral Liner Wear
- Range of Motion .
- Scapular Notching
- Humeral Adapter Tray/Humeral Stem Fatigue ●
- Humeral Stem Fatigue
- Humeral Liner/Humeral Adapter Tray Fatigue
- Humeral Liner Lever Out
- Humeral Liner Pull Out ●
- . Humeral Liner Torque-Out
- Biocompatibility ●
- Bacterial endotoxins (LAL) .
SUBSTANTIAL EQUIVALENCE CONCLUSION
Based on consideration of indications for use, technological characteristics, biocompatibility of the proposed devices, and results of non-clinical testing, it was concluded that the proposed Equinoxe Reverse Humeral Liners and Humeral Adapter Trays demonstrate substantial equivalence to the predicate device.