(135 days)
No
The document describes a mechanical shoulder prosthesis and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is a total shoulder replacement intended to relieve pain and significant disability, which directly aligns with the definition of a therapeutic device.
No
The device is a prosthesis used for total shoulder replacement, specifically designed to relieve pain and disability, not to diagnose a condition.
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 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a shoulder prosthesis, which is an implantable medical device used to replace a damaged shoulder joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use describes the surgical procedure and the conditions for which the prosthesis is indicated (arthropathy associated with massive and non repairable rotator cuff-tear). This is a description of a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the Aequalis Reversed Shoulder Prosthesis is a surgical implant, not an in vitro diagnostic device.
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 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 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 heniprosthesis 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The Aegualis 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 Therefore, the usual Loar of Salersed Shoulder Prosthesis is intended to accomplish these and to 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 base plates with central threaded post and a new coating.
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:
Pull out testing and cadaver testing was performed.
The aim of pull out testing (E1586) is to show the equivalence between the new Aequalis Reversed base plates and the cleared models independently of the post design.
Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations.
To demonstrate the equivalence between the new glenoid base plate and the cleared glenoid base plate the resistance in Pull-out has to be equivalent.
The aim of cadaver testing is to ensure proper use of instruments and implants.
The result shows that primary fixation has been achieved without scapular fracture or other major peri-operative complications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030941, K050316, K061439, K081059, K100142
Reference Device(s)
K122698, K041066, K051075, K092873
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human profiles facing right. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier SAS Mrs. Magalie Hennequin Regulatory Project Manager 161 rue Lavoisier 38334 Montbonnot Saint Martin FRANCE
Re: K132285
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: November 21, 2013 Received: November 22, 2013
Dear Ms. Hennequin:
This letter corrects our substantially equivalent letter of December 5, 2013.
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): K132285
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.
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 ofCDRH, Office ofDevice Evaluation (ODE)
Page 1 of 1
Tornier
Page 5 of69
3
K132285 (1/5)
Implants Chirurgica
510 (k) Summary of Safety and Effectiveness information Traditionnal 510(k) Premarket Notification - Aequalis Reversed Shoulder Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
-
Device name AEQUALIS Reversed Shoulder Prosthesis Trade name: Shoulder Prosthesis Common name: 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 : magalic.hennequin@tornier.com
-
Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
- Equivalent / Predicate device
Aequalis Reversed Shoulder Prosthesis, TORNIER SAS. K030941, K050316. K061439, K081059, K 100142 Aequalis Ascend Flex Shoulder, TORNIER SAS. K122698 Reverse Shoulder Prosthesis. DJO SURGICAL, K041066, K051075, K092873
6) Device description
The Aegualis 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.
Image /page/3/Picture/14 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and has a unique design, with the top bar extending slightly beyond the vertical stem. The logo is black and white, with the "T" and the outline of the hexagon being black against a white background. The logo appears to be a simple, yet distinctive mark, possibly representing a company or brand with a name starting with the letter "T".
S.A.S. au capital de 35 043 008 € TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 FRANCE CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
DEC 0.5 2013
Section 5 - Page 1/ page 5
4
K132285 (2/5)
Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition Therefore, the usual Loar of Salersed Shoulder Prosthesis is intended to accomplish these and to 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 base plates with central threaded post and a new coating.
7) Materials
The glenoid base plate is manufactured from Titanium alloy.
The TiPS coating conforms to the ASTM standard F 1580.
The coating is performed by Eurocoating or APS according to their Master File MAF1760 (for Eurocoating) and MAF 628 (for APS).
8) Indications
Cemented Acqualis 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 cutf-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-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 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 heniprosthesis 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.
Section 5 - Page 2/ page 5 K132285 Tél. : 33 (0)4 76 61 35 00 S.A.S. an capital de 35 043 008 € TORNIER S.A.S. SIRET : 070 501 275 000 21 Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
5
9) Summary of technological characteristics
| Main features of
system characteristics | Acqualis Reversed II
Shoulder System
(new components) | Acqualis Reversed II
Shoulder System | Aequalis Ascend flex | Reverse Shoulder
Prosthesis | |
|--------------------------------------------|-------------------------------------------------------------|-----------------------------------------|------------------------------------------------------|------------------------------------|-------------------------------|
| Material | Glenoid base
plate | Ti6A14V | Ti6Al4V or Ti6Al4V
- HA | Ti6A14V | Alloy titanium |
| Standard | Glenoid base
plate | ISO 5832-3 | ISO 5832-3 | ISO 5832- 3. | - |
| Coating
material | Glenoid base
plate | TiPS Coating | Hydroxylapatite | | |
| Coating
standard | Glenoid base
plate | ASTM F 1580 | ASTM F 1185 | ASTM F 1580 | - |
| Method of fixation
Glenoid component | | Uncemented | Uncemented | Uncemented | Uncemented |
| Glenoid base plate
diameter | | 25mm or 29mm | 25mm or 29mm | NA in reversed
configuration ** | |
| Post | Post design | Threaded post | Press fit post | NA in reversed
configuration ** | Threaded post |
| | Post length | 20 mm to 50mm | 15mm or 25mm | NA in reversed
configuration ** | |
| | External
diameter | 9.5mm +/- 0.05mm | 8.3mm +/- 0.05mm | NA in reversed
configuration ** | |
| | Diameter of
bottom of the
thread | 6.5mm
+0.35/-0.05mm | NA | NA in reversed
configuration ** | |
| Terminal sterilization | | Yes | Yes | Yes | Yes |
| Manufacturers | | Tornier | Tornier | Tornier | DJO |
| K-number | | Pending | K030941
K050316
K061439
K081059*
K100142 | K122698 | K041066
K051075
K092873 |
The indication for use, the manufacturing principle and the sterilization process are similar to the cleared Aequalis Reversed II glenoid base plate.
The design, the coating and the method of fixation of the pending Aequalis Reversed II glenoid base plate is substantially similar to the predicates.
Section 5 - Page 3/ page 5
Image /page/5/Picture/8 description: The image shows a logo with a letter T inside of a hexagon. The letter T is stylized with a thick top bar and a thick vertical line. The hexagon is outlined in black and appears to be a regular hexagon. The logo is simple and geometric.
S.A.S. au capital de 35 043 008 € Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 161. rue Lavoisier R.C.S. : 070 501 275 38334 MONTBONNOT CEDEX CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 18330 MONTBONNOT SAINT MARTIN - FRANCE
6
K132285 (4/5)
Two technological features are different for the new components of the Aequalis Reversed Prosthesis from the predicates:
- The dimension of the post, .
- The design of the post.
The new length of the post length allows to the surgeon to choose the length adapted to the patient's morphology (bone volume) so that the post rest on the bone.
In comparison of the recommended drilled hole diameter of the pending Aequalis Reversed base plate and the predicate, we can see that the pending Reversed base plate is equivalent with the predicates concerning the risk of glenoid's fracture.
To demonstrate that the anchorage of the base plate on the bone is equivalent independently of the post design a pull out testing was conducted on the new Aequalis Reversed II glenoid base plate and the cleared Aequalis Reversed II glenoid base plate.
10) Non-clinical testing
Pull out testing and cadaver testing was performed.
The aim of pull out testing (E1586) is to show the equivalence between the new Aequalis Reversed base plates and the cleared models independently of the post design.
Posts of glenoid base plate (pending and cleared) are impacted in the same foam bloc in several configurations.
To demonstrate the equivalence between the new glenoid base plate and the cleared glenoid base plate the resistance in Pull-out has to be equivalent.
The aim of cadaver testing is to ensure proper use of instruments and implants.
The result shows that primary fixation has been achieved without scapular fracture or other major peri-operative complications.
11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis to the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis can be demonstrated on the following grounds, according to the FDA 's Guidelines for Substantial Equivalence Decision Making Process:
To
16
38
TORNIER S.A.S. Tčl. : 33,(0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier 38334 MONTBONNOT CEDEX R.C.S. : 070 501 275 CODE APE : 3250 A FRANCE
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
Section 5 - Page 4/ page 5
7
K132285 (5/5)
Implants Chirurg
- The new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis are compared to the predicate devices.
- The new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis have the . same intended use as the cleared glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis.
- Major technological characteristics are equivalent between the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis and the predicate devices:
- Equivalence of general features -
- Equivalent means of fixation -
- Equivalent materials -
Therefore, in the light of the above information, the new glenoid base plate of the Aequalis Reversed II Shoulder Prosthesis are found to be equivalent to the predicate devices.
Image /page/7/Picture/10 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be constructed from thick lines, giving it a blocky appearance. The hexagon provides a border around the 'T', creating a contained and geometric design.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 S.A.S. au capital de 35 043 008 € Fax : 33 (0)4 76 61 35 33 SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MON'TBONNOT SAINT MARTIN - FRANCE
Section 5 - Page 5/ page 5