(30 days)
Not Found
No
The description focuses on the mechanical components and materials of a shoulder implant system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a shoulder system used for joint replacement procedures due to degenerative diseases or fractures, which aligns with the definition of a therapeutic device as it is intended to treat a medical condition.
No
The device is a shoulder implant system (prosthesis) designed for joint replacement procedures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like humeral stems, glenoids, humeral heads, replicator plates, and glenospheres, which are manufactured from materials like titanium alloy and cobalt-chrome alloy. This indicates a hardware-based medical device, not a software-only one.
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 replacing or repairing the glenohumeral joint due to degenerative diseases or fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis (stems, heads, glenoids, plates, glenospheres) which are surgically implanted. This is consistent with a medical device for treatment, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
The device is a medical device intended for surgical implantation to treat musculoskeletal conditions.
N/A
Intended Use / Indications for Use
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems and all 0 Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be o 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.
- 0 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:
| 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 (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS
Device Description
The Equinoxe Shoulder System is comprised of primary, fracture and reverse product lines for use in hemi- and total-shoulder joint replacement procedures. The Equinoxe Primary and Fracture system utilize both cemented and press-fit, semi-constrained glenohumeral prostheses for use in hemi-shoulder and totalshoulder joint replacement procedures, and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus.
The Equinoxe Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional rotator cuff. The Equinoxe Reverse Shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems.
The proposed fixed angle replicator plates are manufactured from wrought titanium alloy (Ti-6Al-4V E.L.I) per ASTM F136 and connect to the humeral stem via a spherical bowl and are locked in place using the previously cleared primary torque-defining screw. The replicator plate attaches to the humeral head using a morse taper. The mating features on the proposed replicator plates (specifically the morse taper geometry and the spherical bowl geometry) are identical to the predicate part, only the offset and angular adjustability have been altered.
The proposed humeral heads are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75 and provide an articulating surface for hemi and total joint replacement. They feature female taper geometry for mating with proposed and predicate replicator plate designs. No design changes have been made to this device. It is a material change only.
The proposed glenospheres are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75and connect to the plate via an apical hole screw and slip fit with oval shaped plate. No design changes have been made to this device. It is a material change only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, proximal humerus, mid-humerus, humeral head
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)
Fatigue testing was conducted to verify the safety and effectiveness of the proposed Exactech Equinoxe Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres. These tests were done to mitigate the risks that were affected by the proposed changes. Risks that were not affected by the new design were not re-verified. Results from these tests and analyses provided within this 510(k) demonstrate that the Exactech Equinoxe Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres are substantially equivalent to the identified predicate devices and will be safe for clinical use.
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 a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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 Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K102951
N 102731
Trade/Device Name: Equinoxe Fixed-Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS Dated: October 1, 2010 Received: October 5, 2010
Dear Mr. Cuthbert:
This letter corrects our substantially equivalent letter of November 4, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rollowed your wo determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of 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
Page 2 - Mr. Graham L. Cuthbert
(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 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 contact 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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 Total Shoulder - Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - Indications for Use
510(k) Number (if known): K102951
Device Name: Equinoxe Fixed-Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres.
INDICATIONS FOR USE:
Sign-Oft)
Sign-Oft)
Prative Devices
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 0 Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may be o 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.
- 0 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:
| Indications | |||
|---|---|---|---|
| Stock Number K102951 | √ | √ | 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
3
Exactech® Equinoxe® Total Shoulder - Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - Indications for Use
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.
X Prescription Use (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)
Sonitu for mxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
and/or
510(k) Number K102951
4
1/5
Exactech® Equinoxe® Total Shoulder - Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - Substantial Equivalence
| I. Company: | Exactech, Inc.
2320 N.W. 66 th Court
Gainesville, FL 32653 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Contact Person: | Graham L. Cuthbert, Regulatory Affairs Specialist II |
| Date: | October 1 st , 2010 |
| II. Proprietary Name: | Exactech Equinoxe Fixed Angle Replicator Plate
Exactech Equinoxe Humeral Heads
Exactech Equinoxe Glenosphere |
| Common Name: | Total Shoulder Prosthesis
Reverse Total Shoulder Prosthesis |
NOV - 4 2010### Classification Name:
- Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR . 888.3650, Class II, Product Code KWT)
- Prosthesis, Shoulder, Semi-constrained, metal/polymer cemented (21 CFR . 888.3660.
Class II, Product Code KWS)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.
| 510(k) Number | Trade of Proprietary Model Name | Manufacturer |
|---|---|---|
| K042021 | Equinoxe Total Shoulder System | Exactech, Inc |
| K063569 | Equinoxe Reverse Total Shoulder System | Exactech, Inc |
IV. Device Description:
The Equinoxe Shoulder System is comprised of primary, fracture and reverse product lines for use in hemi- and total-shoulder joint replacement procedures. The Equinoxe Primary and Fracture system utilize both cemented and press-fit, semi-constrained glenohumeral prostheses for use in hemi-shoulder and totalshoulder joint replacement procedures, and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus.
The Equinoxe Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional rotator cuff. The Equinoxe Reverse Shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems.
5
K102951 2/5
Exactech® Equinoxe® Total Shoulder - Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - 510(k) Summary of Safety and Effectiveness
The proposed fixed angle replicator plates are manufactured from wrought titanium alloy (Ti-6Al-4V E.L.I) per ASTM F136 and connect to the humeral stem via a spherical bowl and are locked in place using the previously cleared primary torque-defining screw. The replicator plate attaches to the humeral head using a morse taper. The mating features on the proposed replicator plates (specifically the morse taper geometry and the spherical bowl geometry) are identical to the predicate part, only the offset and angular adjustability have been altered.
The proposed humeral heads are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75 and provide an articulating surface for hemi and total joint replacement. They feature female taper geometry for mating with proposed and predicate replicator plate designs. No design changes have been made to this device. It is a material change only.
The proposed glenospheres are manufactured from Cast Cobalt-Chrome Alloy (Co-28Cr-6Mo) per ASTM F75and connect to the plate via an apical hole screw and slip fit with oval shaped plate. No design changes have been made to this device. It is a material change only.
Intended Use of the Device V.
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment.
- The cemented primary humeral stem, long/revision stem, fracture stems . and all Equinoxe glenoids are intended for cemented fixation.
- The press-fit humeral stems are intended for press-fit applications but may . be used with bone cement at the discretion the surgeon.
- The reverse humeral components are intended to be used in cemented ● applications or in revision cases when the humeral component is wellfixed/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 arthro plasty 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 |
6
K102951 3/5
Exactech® Equinoxe® Total Shoulder - Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - 510(k) Summary of Safety and Effectiveness
| P | L/R | F | Indications |
|---|---|---|---|
| √ | 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 (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.
Rationale for Substantial Equivalence VI.
Equinoxe Fixed Angle Replicator Plate:
- Intended Use / Indications for Use. The Equinoxe Fixed Angle Replicator ● Plates and predicate devices are intended for use in total shoulder joint replacement and have identical indications for use.
- The Equinoxe Fixed Angle Replicator Plates and predicate � Materials. devices are composed of equivalent biocompatible materials conforming to recognized industry standards for permanent implants.
- Design Features. The Equinoxe Fixed Angle Replicator Plates and predicate ● devices have the same design features.
- The Equinoxe Fixed Angle Replicator Plates and predicate ● Dimensions. devices have identical geometry for mating with the previously cleared humeral stems and humeral heads. The only difference is a new offset option and a reduction in the through hole diameter to prevent angulation of the plate. This has no effect on the mechanical strength of the design.
- Packaging and Sterilization. The Equinoxe Fixed Angle Replicator Plates . and predicate devices are packaged and sterilized using the same materials and processes.
- Device Shelf Life. The Equinoxe Fixed Angle Replicator Plates and predicate . devices have the same shelf life.
7
K102951 4/5
Exactech® Equinoxe® Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) - 510(k) Summary of Safety and Effectiveness
Cast Humeral Heads:
- Intended Use / Indications for Use. The Equinoxe Cast Humeral Heads and . predicate devices are intended for use in total shoulder joint replacement and have identical indications for use.
- Materials. The Equinoxe Cast Humeral Heads and predicate devices are . composed of Co-28Cr-6Mo Alloys which are biocompatible materials conforming to recognized industry standards for permanent implants.
- Design Features. The Equinoxe Cast Humeral Heads and predicate devices ● have the same design features.
- Dimensions. The Equinoxe Cast Humeral Heads and predicate devices have . identical geometry.
- Packaging and Sterilization. The Equinoxe Cast Humeral Heads and ● predicate devices are packaged and sterilized using the same materials and processes.
- Device Shelf Life. The Equinoxe Cast Humeral Heads and predicate devices ● have the same shelf life.
Cast Glenospheres:
- Intended Use / Indications for Use. The Equinoxe Cast Glenospheres and . predicate devices are intended for use in reverse total shoulder joint replacement and have identical indications for use.
- The Equinoxe Cast Glenospheres and predicate devices are Materials. . composed of Co-28Cr-6Mo Alloys which are biocompatible materials conforming to recognized industry standards for permanent implants.
- Design Features. The Equinoxe Cast Glenospheres and predicate devices . have the same design features.
- Dimensions. The Equinoxe Cast Glenospheres and predicate devices have . identical geometry.
- Packaging and Sterilization. The Equinoxe Cast Glenospheres and predicate ● devices are packaged and sterilized using the same materials and processes.
- Device Shelf Life. The Equinoxe Cast Glenospheres and predicate devices ● have the same shelf life.
VII. Summary of Non-Clinical Performance Data
Fatigue testing was conducted to verify the safety and effectiveness of the proposed Exactech Equinoxe Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres. These tests were done to mitigate the risks that were affected by the proposed changes. Risks that were not affected by the new design were not re-verified.
Substantial Equivalence Conclusion
Results from these tests and analyses provided within this 510(k) demonstrate that the Exactech Equinoxe Fixed Angle Replicator Plates, Cast Humeral Heads, and
8
K102951 5/5
Exactech® Equinoxe® Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenospheres Special 510(k) -- 510(k) Summary of Safety and Effectiveness
·
Cast Glenospheres are substantially equivalent to the identified predicate devices and will be safe for clinical use.