(18 days)
Not Found
No
The document describes a mechanical shoulder implant system and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The performance studies focus on mechanical and geometric analyses, not data-driven algorithms.
Yes
The device is an orthopedic implant (shoulder system) intended to treat degenerative diseases, fractures, and other pathologies of the glenohumeral joint, which directly addresses the management of a disease or condition.
No
Explanation: The device is an orthopedic implant (shoulder system) used for treatment of joint diseases and fractures, not for diagnosis.
No
The device description and intended use clearly describe physical implants (glenospheres, glenoid plates, compression screws, humeral stems, humeral heads) used in shoulder arthroplasty, 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 involves physical intervention within the body.
- Device Description: The device is described as a shoulder system with components like humeral stems, glenoids, and humeral heads, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a surgical implant used for arthroplasty (joint replacement), which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Equinoxe Shoulder System is in skeletally manre individuals with degeneralive 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 (I'), 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 degeneralive 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 foss 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 humens 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 ceniented use only.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWS, KWT
Device Description
The modifications proposed by this submission describe minor geometry changes to the standard offering of Equinoxe glenospheres, glenoid plates, and compression screws; these geometry modifications are the entire basis for proposed Reverse Shoulder line extensions (expanded offset glenospheres, posterior and superior augmented glenoid plates, +10mm extended cage glenoid plate, and longer compression screws).
All proposed components are designed to interface and articulate with the Equinoxe Shoulder system and are supplied sterile.
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)
Mechanical tests, simulated-use tests, engineering analyses, and a clinical literature summary demonstrate the proposed Exactech Equinoxe Reverse Shoulder line extensions are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- Cadaver lab validation demonstrating the design features. ●
- Geometric computer analysis to evaluate the relationship between the reverse ● shoulder design parameters and ROM, impingement, and stability.
- Dynamic test at worst case physiological load in a polyurethane bone substitute in . order to evaluate initial fixation, loosening, and disassociation.
- Clinical literature summary related to cuff tear arthroplasty and reverse shoulder ● arthroplasty.
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.
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
§ 888.3660 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized symbol. The symbol is a representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Exactech, Incorporated Lindy Knisely, RN Regulatory Affairs Specialist 2320 N.W.66th Court Gainesville, Florida 32653
Re: K110708
Trade/Device Name: Exactech® Equinoxe® Reverse Shoulder System™ Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWS, KWT Dated: March 11, 2011 Received: March 14, 2011
Dear Ms. Knisely:
This letter corrects our substantially equivalent letter of April 1, 2011.
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical (21 OFF art 607); asseming (21 CFR 803); good manufacturing practice requirements as set device thatou develop (2) CFR Part 820); and if applicable, the electronic form in the quality of oversions (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 if you don't be openits and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part the regulation ontined, "Thisolulating of adverse events under the MDR regulation (21 CFR Part 803), please go to
(21 Of 11 Pater attact) Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Exactech® Equinoxe® Reverse Shoulder™ Linc Extensions Special 510(k) - Indications for Use
510(k) Number: KI10708
Device Name(s): Exactech® Equinoxe® Reverse Shoulder System™
The Equinoxe Shoulder System is in skeletally manre individuals with degeneralive 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 (I'), 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 degeneralive 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 foss 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 humens 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 ceniented use only.
Over-The-Counter Use Prescription Use and/or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
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CORH/1002 concurrence
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K110708
p2/2
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Exactech® Equinoxe® Reverse Shoulder™ Line Extensions Special 510(k) - Indications for Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mckern
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K110708
4
Exactech® Equinoxe® Reverse Shoulder™ Line Extensions Special 510(k) - Section 07 - 510(k) Summary
| I. | Submitter Information
Company: | Exactech, Inc
2320 N.W. 66th Court
Gainesville, Florida 32653 |
|-----|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | March 11, 2011 |
| | Contact Person: | Lindy Knisely, RN
Regulatory Affairs Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| II. | Device Information
Proprietary Name: | Exactech Equinoxe® Reverse Shoulder™ |
| | Common Name: | Laterally Offset Glenospheres
Posterior Augment Glenoid Plate
Superior Augment Glenoid Plate
Extended Cage Glenoid Plate
Compression Screws |
| | Classification Name: | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
Cemented (21 CFR 888.3650 [Shoulder joint
metal/polymer non-constrained cemented prosthesis], Class
II, Product Code KWT)
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer
Cemented (21 CFR 888.3660 [Shoulder joint
metal/polymer semi - constrained cemented prosthesis],
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 |
|---|---|---|
| K063569 | Exactech Equinoxe Reverse Shoulder | Exactech, Inc |
| K093275 | Exactech Equinoxe Reverse Shoulder | Exactech, Inc |
IV. Device Description
The modifications proposed by this submission describe minor geometry changes to the standard offering of Equinoxe glenospheres, glenoid plates, and compression screws; these geometry modifications are the entire basis for proposed Reverse Shoulder line extensions (expanded offset glenospheres, posterior and superior augmented glenoid plates, +10mm extended cage glenoid plate, and longer compression screws).
5
Exactech® Equinoxe® Reverse Shoulder™ Line Extensions Special 510(k) - Section 07 - 510(k) Summary
All proposed components are designed to interface and articulate with the Equinoxe Shoulder system and are supplied sterile.
V. Indications 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.
- o 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 0 used with bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented applications 0 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. 0
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
6
Exactech® Equinoxe® Reverse Shoulder™ Line Extensions Special 510(k) - Section 07 - 510(k) Summary
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:
- Intended Use. Exactech Equinoxe Reverse Shoulder line extensions and ● predicate devices are intended for use in Total Shoulder Arthroplasty.
- Materials. Exactech Equinoxe Reverse Shoulder line extensions and predicate . devices are composed of equivalent materials conforming to recognized industry standards for permanent implants.
- Dimensions. Exactech Equinoxe Reverse Shoulder line extensions and predicate ● devices are available in equivalent size ranges.
- Sterilization processes. Exactech Equinoxe Reverse Shoulder line extensions and ● predicate devices are provided sterile for single use and conform to recognized industry standards.
- Performance specifications. Exactech Equinoxe Reverse Shoulder line . extensions and predicate devices withstand clinically relevant biomechanical loads.
Substantial Equivalence Conclusion
Mechanical tests, simulated-use tests, engineering analyses, and a clinical literature summary demonstrate the proposed Exactech Equinoxe Reverse Shoulder line extensions are substantially equivalent to the predicate devices. A summary of these tests and analyses are as follows:
- Cadaver lab validation demonstrating the design features. ●
- Geometric computer analysis to evaluate the relationship between the reverse ● shoulder design parameters and ROM, impingement, and stability.
- Dynamic test at worst case physiological load in a polyurethane bone substitute in . order to evaluate initial fixation, loosening, and disassociation.
- Clinical literature summary related to cuff tear arthroplasty and reverse shoulder ● arthroplasty.