(86 days)
Not Found
No
The summary describes a mechanical implant system and the performance studies are based on mechanical testing and geometric analysis, not AI/ML algorithms. There are no mentions of AI, ML, or related concepts.
Yes
The device is a reverse shoulder system designed to relieve pain and restore function in individuals with degenerative diseases of the glenohumeral joint and a deficient rotator cuff, or for failed glenohumeral joint replacement. These are therapeutic objectives.
No
The device is a reverse shoulder joint replacement system, indicated to relieve pain and restore function in individuals with degenerative diseases of the glenohumeral joint and a deficient rotator cuff. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists physical components such as humeral stems, adapter plates, glenospheres, liners, and screws, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Exactech Equinoxe™ Reverse Shoulder System is a prosthetic implant designed for surgical implantation in the shoulder joint. It is a physical device used to replace damaged joint components.
- Intended Use: The intended use is to relieve pain and restore function in skeletally mature individuals with specific shoulder conditions, which is achieved through surgical implantation, not through testing bodily samples.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, the Exactech Equinoxe™ Reverse Shoulder System falls under the category of a medical device (specifically, a prosthetic implant), not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Product codes (comma separated list FDA assigned to the subject device)
KWT, KWS
Device Description
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 totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glenohumeral joint, Shoulder
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, engineering analyses, and simulated surgical (sawbones and cadaver) implantations were conducted to demonstrate the safety and effectiveness of the devices that compose the Equinoxe™ Reverse Shoulder System and support the claim of substantial equivalence to the predicates listed above; a summary of these tests and analyses are as follows:
- A dynamic loading study in which the stability of the Equinoxe Reverse Shoulder was assessed in a polyurethane bone substitute (TR-2006-052) and in a cadaver (TS-2006-024). The glenoid plate/glenosphere micromotion measurements obtained in this study are compared to that associated with the Depuy Delta III and Encore RSP components when subjected to a similar loading pattern.
- A comparative assessment of the glenosphere center of rotation that demonstrates the location of the center of rotation is similar for the Equinoxe and Delta III designs. This observation in conjunction with the micromotion test results (TR-2006-052 and TS-2006-024) suggest that the low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder is applicable to the Equinoxe™ Reverse Shoulder design (TR-2006-053).
- A geomettic analysis of the Grammont Reverse Shoulder Prosthesis-an evaluation of the relationships between prosthetic design parameters and clinical failure modes (TR-2006-028). This assessment was used to optimize the design parameters associated with the Equinoxe design in order to maximize ROM and minimize inferior impingement.
- A geometric analysis vetification study that demonstrates the Equinoxe Reverse Shoulder achieves an increase in the amount of motion and a decrease in the amount of inferior impingement (a measure of motion and stability, indicative of scapular notching) while maintaining a similar amount of jump distance (a measure of stability, indicative of the probability of dislocation) relative to the Grammont/Delta III design (TR-2006-029).
- A finite element analysis that demonstrates the geometry of the proposed devices is not subject to fracture when subjected to a worst-case load (TR-2006-039).
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.
K021478, K050315, K062116, K030941, K041873, K050316, K052906, K060704, K053274, K041066, K051075, K052086
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
510(k) Summary
2320 NW 66TH COURT GAINESVILLE, F1 32653
352-377-1140 FAX 352-378-2617
FEB 2 3 2007 Company: Exactech, Inc Date: November 28, 2006 Contact Person: Amnon Talmor, Regulatory Affairs Representative Proprietary Name: Exactech Equinoxe™ Reverse Shoulder System Common Name: Reverse Shoulder Prosthesis 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
- Depuy Delta III Reverse Shoulder (#K021478, #K050315, #K062116) .
- Tornier Reverse Shoulder (#K030941, #K041873, #K050316) .
- Zimmer BF Reverse Shoulder (#K052906, #K060704)
- . Zimmer Anatomica Reverse Shoulder (#K053274)
- . Encore Reverse Shoulder (#K041066, #K051075, #K052086)
Device Description
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 totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.
Indications for Use
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use. Equinoxe™ Reverse Shoulder System and predicate devices are intended . for use in total reverse shoulder joint replacement and have similar indications for use statements.
A Great Day in the O.H
Page 1 of 2
EXACTECH exists to inques the economing this activity ond independence. We do his through interest inde-station and connish one commisses of services on services on services
1'+
1
ે ૮ રે રેડા દિવે
- Materials. Equinoxe " Reverse Shoulder System and predicate devices are composed of . equivalent materials conforming to recognized industry standards for permanent implants.
- Dimensions. Equinoxe™ Reverse Shoulder System and predicate device components ● are available in equivalent size ranges.
- Sterilization processes. Equinoxe™ Reverse Shoulder System and predicate devices are . sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Equinoxe™ Reverse Shoulder System and predicate . devices conform to recognized performance standards for total shoulder joint replacement devices.
Summary of Non-Clinical Performance Data
Mechanical tests, engineering analyses, and simulated surgical (sawbones and cadaver) implantations were conducted to demonstrate the safety and effectiveness of the devices that compose the Equinoxe™ Reverse Shoulder System and support the claim of substantial equivalence to the predicates listed above; a summary of these tests and analyses are as follows:
- A dynamic loading study in which the stability of the Equinoxe Reverse Shoulder was . assessed in a polyurethane bone substitute (TR-2006-052) and in a cadaver (TS-2006-024). The glenoid plate/glenosphere micromotion measurements obtained in this study are compared to that associated with the Depuy Delta III and Encore RSP components when subjected to a similar loading pattern.
- A comparative assessment of the glenosphere center of rotation that demonstrates the . location of the center of rotation is similar for the Equinoxe and Delta III designs. This observation in conjunction with the micromotion test results (TR-2006-052 and TS-2006-024) suggest that the low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder is applicable to the Equinoxe™ Reverse Shoulder design (TR-2006-053).
- A geomettic analysis of the Grammont Reverse Shoulder Prosthesis-an evaluation of . the relationships between prosthetic design parameters and clinical failure modes (TR-2006-028). This assessment was used to optimize the design parameters associated with the Equinoxe design in order to maximize ROM and minimize inferior impingement.
- A geometric analysis vetification study that demonstrates the Equinoxe Reverse . Shoulder achieves an increase in the amount of motion and a decrease in the amount of inferior impingement (a measure of motion and stability, indicative of scapular notching) while maintaining a similar amount of jump distance (a measure of stability, indicative of the probability of dislocation) relative to the Grammont/Delta III design (TR-2006-029).
- A finite element analysis that demonstrates the geometry of the proposed devices is not � subject to fracture when subjected to a worst-case load (TR-2006-039).
Substantial Equivalence Conclusion
Results from mechanical tests and engineering analyses provided within this 510(k) demonstrate that the Equinoxe™ Reverse Shoulder System is substantially equivalent to the identified predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Exactech, Inc % Mr. Amnon Talmor Regulatory Affairs Representative 2320 NW 66th Court Gainesville, Florida 32653
FEB 2 3 2007
Re: K063569
Trade/Device Name: Equinoxe Reverse Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT Dated: November 27, 2006 Received: November 29, 2006
Dear Mr. Talmor:
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 for are cased in 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Amnon Talmor
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Corbace Buehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech®, Inc.
Indications for Use
510(k) Number (if known):
Device Name: Equinoxe Reverse Shoulder System
INDICATIONS FOR USE:
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Prescription Use _ X (Part 21 CFR 801 Subpart D) and/or 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)
Clarlare Buchnd
(Division Signer)
(Division Sign-Off) Division of General, Restorative, and Neurological General, Resto
510(k) Number K063569
Page 1 of 1