(161 days)
No
The document describes a mechanical shoulder prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total shoulder replacement intended for the relief of pain and significant disability following arthropathy, which is a therapeutic purpose.
No
The device is a prosthesis (an implanted medical device) used for surgical treatment, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implant (shoulder prosthesis) composed of humeral and glenoid parts, not software.
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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The text clearly describes the Aequalis Reversed Shoulder Prosthesis as a surgical implant used to replace a damaged shoulder joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to relieve pain and disability by replacing the shoulder joint in patients with specific conditions. This is a therapeutic intervention, not a diagnostic test.
The device is a surgical implant used for treatment, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Note: Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
Product codes
PHX, KWS
Device Description
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional. Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification consists in the addition of glenoid sphere in Titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
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)
Non-clinical testing was performed including pull out testing, fatigue testing, and wear testing.
Pull out testing: "The aim of pull out testing is to show the equivalence between the new Aequalis Reversed glenoid sphere and the cleared models independently of the material. To demonstrate the equivalence between the new glenoid sphere and the cleared glenoid sphere the resistance in Pull-out has to be equivalent."
Fatigue testing: "The aim of fatigue testing is to evaluate the behavior of the new Aequalis Reversed glenoid sphere and cleared baseplate assembly. To evaluate the behavior of the new glenoid sphere no relative motion and no disassembly have to be observed."
Wear testing: "The aim of wear testing is to compare the new Aequalis Reversed glenoid sphere in Titanium and the cleared models in Cocr wear characterictics when facing a UHMWPE material. To demonstrate the equivalence between the new glenoid sphere and the cleared glenoid sphere the wear characterictics have to be equivalent in terms of: weight loss, wear rate and shape and size of the particles generated."
Results: "The results of these tests demonstrate the equivalence between the new Aequalis Reversed glenoid sphere and the cleared Aequalis Reversed glenoid sphere."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030941, K061439, K081059, K100142
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier SAS Ms. Magalie Hennequin Regulatory Projects Manager 161 rue Lavoisier 38330 Montbonnot Saint Martin FRANCE
Re: K140478
Trade/Device Name: Aequalis Reversed Shoulder Prosthesis Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: July 4, 2014 Received: July 7, 2014
Dear Ms. Hennequin:
This letter corrects our substantially equivalent letter of August 6, 2014.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
Page 2 - Ms. Magalie Hennequin
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/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/Resourcesfor You/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
Indications for Use
510(k) Number (if known):
Device Name: Aequalis Reversed Shoulder Prosthesis
Indications For Use:
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Note: Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| --------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
GFM-00000123 REV A - Tornier
Appendix III
3
Implants Chirur
510 (k) Summary of Safety and Effectiveness information Traditional 510(k) Premarket - Aequalis Reversed Shoulder Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
| 1) Device name | |
|---|---|
| Trade name: | AEQUALIS Reversed Shoulder Prosthesis |
| Common name: | Shoulder Prosthesis |
| Classification name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
-
Submitter : TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
-
Company contact : Tornier Mrs Magalie Hennequin Regulatory project Manager 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 03 Fax: 00 33 4 76 61 35 59 e-mail : magalie.hennequin@tornier.com
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
5) Equivalent / Predicate device :
Aequalis Reversed Shoulder Prosthesis - CoCr Glenosphere, TORNIER SAS, K030941, K061439, K081059, K100142
Comprehensive Reverse Shoulder - Titanium Glenosphere, BIOMET, K131353
6) Device description :
The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.
Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to reduce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.
TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 38334 MONTBONNOT CEDEX FRANCE
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
GFM-00000123 REV A - Tornier
4
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification consists in the addition of glenoid sphere in Titanium.
7) Materials :
The glenoid sphere is manufactured from Titanium alloy.
8) Indications :
Cemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated with the massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cufftear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cufftear. The humeral components are for non-cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-orosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemiprosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Note: Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
Image /page/4/Picture/15 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from thick lines and has a geometric, almost architectural appearance. The hexagon provides a border around the 'T', creating a contained and symmetrical design.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
GFM-00000123 REV A - Tornier
Section 5 - Page 2/ page 4
5
9) Summary of technological characteristics
Table 1: Main features comparison
| Main features or
system characteristics | | Aequalis Reversed II
Shoulder System (new
components - Titanium
glenosphere) | Aequalis Reversed II
Shoulder System -
CoCr Glenosphere | Comprehensive -
Titanium Glenosphere | SE? |
|--------------------------------------------|--------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------|-----|
| Material | | Titanium | CoCr | Titanium | Yes |
| Standard | | ASTM F136 / ISO 5832-3 | ISO 5832-12 ou ISO
5832-7 | | Yes |
| Method of fixation with
the base plate | | Taper + Glenoid sphere
Screw | Taper + Glenoid sphere
Screw | Taper + Glenoid
sphere Screw | Yes |
| Diameter
of glenoid
sphere | Centered | 36mm, 42mm | 36mm, 42mm | 36mm, 41mm | Yes |
| | Tilted | 36mm, 42mm
Excentration +2mm | 36mm, 42mm
Excentration +2mm | | Yes |
| | Off-centered | 36mm, 42mm
Lateralization +4mm | 36mm, 42mm
Lateralization +4mm | 36mm, 41mm
Lateralization +3mm,
+6mm | Yes |
| Terminal sterilization | | Yes | Yes | Yes | Yes |
| Manufacturer | | Tornier | Tornier | Biomet | - |
| K-number | | Pending | K030941, K061439,
K081059, K100142 | K131353 | - |
The design, the indication for use, the manufacturing principle, the method of fixation of the new sphere on the base plate and the sterilization process are not modified for the pending glenoid sphere to the predicate.
10) Non-clinical testing
Pull out testing, fatigue testing and wear testing were performed.
-
The aim of pull out testing is to show the equivalence between the new Aequalis Reversed glenoid sphere and the cleared models independently of the material.
To demonstrate the equivalence between the new glenoid sphere and the cleared glenoid sphere the resistance in Pull-out has to be equivalent. -
The aim of fatigue testing is to evaluate the behavior of the new Aequalis Reversed glenoid sphere and cleared baseplate assembly.
To evaluate the behavior of the new glenoid sphere no relative motion and no disassembly have to be observed.
Image /page/5/Picture/11 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is composed of thick lines and has a geometric design. The logo appears to be a monochrome image, with the lines and shapes in black against a white background.
TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
6
- The aim of wear testing is to compare the new Aequalis Reversed glenoid sphere in Titanium and the cleared models in Cocr wear characterictics when facing a UHMWPE material.
To demonstrate the equivalence between the new glenoid sphere and the cleared glenoid sphere the wear characterictics have to be equivalent in terms of: weight loss, wear rate and shape and size of the particles generated.
The results of these tests demonstrate the equivalence between the new Aequalis Reversed glenoid sphere and the cleared Aequalis Reversed glenoid sphere.
11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new glenoid sphere of the Aequalis Reversed II Shoulder Prosthesis to the predicate can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- The new glenoid sphere of the Aequalis Reversed II Shoulder Prosthesis is compared to the predicate devices.
- The new glenoid sphere of the Aequalis Reversed II Shoulder Prosthesis has the same intended use as the cleared glenoid sphere of the Aequalis Reversed II Shoulder Prosthesis.
- Major technological characteristics are equivalent between the new glenoid sphere of the -Aequalis Reversed II shoulder prosthesis and the predicate devices:
- Equivalence of general features -
- . Equivalent means of fixation
- Equivalent material -
- -Equivalent prosthetic dimensions
Therefore, in the light of the above information, the new glenoid sphere of the Aequalis Reversed II Shoulder Prosthesis is found to be equivalent to the predicate devices
Image /page/6/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by two horizontal lines at the top and bottom, connected by a vertical line in the center. The logo is black and white and has a simple, geometric design. The logo appears to be a trademark or symbol for a company or organization.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE