(107 days)
No
The document describes a mechanical shoulder prosthesis and its intended use, with no mention of software, algorithms, or any AI/ML components.
Yes
The device is a total shoulder replacement intended for the relief of pain and significant disability, which directly addresses a medical condition and aims to improve a patient's health.
No
The device description clearly states its purpose is to be a total shoulder replacement for the relief of pain and disability, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical shoulder prosthesis composed of humeral and glenoid parts, intended for surgical implantation. It also mentions modifications involving humeral stems and metaphyses with hydroxylapatite coating, which are physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "Shoulder Prosthesis" intended for surgical implantation to replace a damaged shoulder joint. It is a physical implant used within the body, not a tool for analyzing samples outside the body.
- Intended Use: The intended use describes the surgical procedure and the conditions it treats (arthropathy associated with rotator cuff tears), not the analysis of biological samples.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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-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 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, HSD
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 submission consists of:
- the addition of humeral stems with hydroxylapatite coating,
- the addition of 2 sizes of metaphyses with hydroxylapatite coating, •
- the update of the Aequalis Reversed Shoulder Prosthesis indications for use. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 not necessary to determinate substantial equivalence between the new uncemented stems and new uncemented metaphysis of the Aequalis Reversed Shoulder Prosthesis and the cited predicate devices.
- The design of the new components of the Aequalis Reversed Shoulder Prosthesis (uncemented . stems and uncemented metaphyses) is identical to the design of predicate Aequalis Reversed Shoulder Prosthesis (K030941, K041873, K050316, K061439, and K081059) except for the addition of an HA coating.
- The raw material of the new components of the Aequalis Reversed Shoulder Prosthesis -(uncemented stems and uncemented metaphyses) is identical to the raw material of predicates Aequalis Reversed Fracture Shoulder Prosthesis (K082120) and Delta Xtend (K062250, K071379, and K091751).
- The coating material of the new components of the Aequalis Reversed Shoulder Prosthesis -(uncemented stems and uncemented metaphyses) is identical to the coating material of the predicate Aequalis Reversed Fracture Shoulder Prosthesis (K082120).
- The fixation method of the new humeral components of the Aequalis Reversed Shoulder Prosthesis is identical to the fixation method of the predicates Aequalis Reversed Fracture Shoulder Prosthesis (K082120) and Delta Xtend (K062250, K071379, and K091751).
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.
K030941, K041873, K050316, K061439, K081059
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.
K082120, K062250, K071379, K091751
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 is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier Mrs. Severine Bonneton Regulatory Affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex FRANCE
Re: K100142
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, HSD Dated: May 3, 2010 Received: May 5, 2010
Dear Mrs. Bonneton:
This letter corrects our substantially equivalent letter of May 6, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
Page 2 - Mrs. Severine Bonneton
(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/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): K100142
Device Name: Aequalis Reversed Shoulder Prosthesis
Indications For Use:
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 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.
3
Uncemented 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 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 of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| K100142 |
510(k) Number
4
Implants Chirurgicaux
MAY - 5 2010
Summary of Safety and Effectiveness information 510(k) Premarket Notification - Aequalis Reversed Shoulder Prosthesis
Date: April 29th, 2010
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
Aequalis Reversed Shoulder Prosthesis Trade name: Common name: Total-Shoulder System and Hemi-Shoulder System Classification name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Shoulder, Hemi-, Humeral, Metallic uncemented
2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
3) Company contact
Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail: severine.bonneton@tornier.fr
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWS, HSD |
5) Equivalent / Predicate device
Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439, K081059.
Aequalis Reversed Fracture Shoulder System, TORNIER SA, K082120. Delta Xtend Reverse Shoulder System, DEPUY, K062250, K071379, K091751.
Image /page/4/Picture/16 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with a horizontal bar at the top and a vertical stem that extends downwards. The hexagon provides a clear border around the central 'T' symbol, making it stand out.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tહા. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 1/ page 4
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGIE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
5
Implants Chirurgicaux
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.
The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.
The present device modification submission consists of:
- the addition of humeral stems with hydroxylapatite coating,
- the addition of 2 sizes of metaphyses with hydroxylapatite coating, •
- the update of the Aequalis Reversed Shoulder Prosthesis indications for use. .
7) Materials
The stems are manufactured from titanium alloy. The metaphyses are manufactured from cobalt-chromium alloy and ultra high molecular weight polyethylene (UHMWPE).
The hydroxylapatite coating conforms to ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.
8) 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 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.
Section 5 . Page 2/ page 4
Image /page/5/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is designed with a thick vertical line and a horizontal bar at the top, with additional decorative elements on either side of the vertical line. The logo appears to be a simple, possibly vintage design, rendered in black and white.
TORNIER S.A.S. 161. rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Ticl. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
S1EGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
6
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.
Implants Chirurgicaux
KIDOIYA * >14
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 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.
| Main features or system
characteristics | | Aequalis Reversed
(new components) | Aequalis Reversed | Aequalis Reversed
Fracture | Delta Xtend
Reverse Shoulder |
|--------------------------------------------|-----------------|---------------------------------------|---------------------------------------------------------|-------------------------------|---------------------------------|
| Materials | Humeral
stem | Ti6Al4V | CoCr | Ti6Al4V | CoCr + UHMWPE |
| | Metaphysis | CoCr + UHMWPE | CoCr + UHMWPE | - | CoCr + UHMWPE |
| Coating
material | Humeral part | Hydroxylapatite | uncoated | Hydroxylapatite | Hydroxylapatite or
uncoated |
| Size | Humeral
stem | 4 diameters
4 lengths | 4 diameters
4 lengths | 5 diameters
4 lengths | 5 diameters
9 lengths |
| | Metaphysis | 2 sizes:36 or 42 mm | 2 sizes:36 or 42 mm | 40 mm | 2 sizes |
| Stem / metaphysis type | | Modular | Modular | Monobloc | Monobloc or
modular |
| Method of fixation
Humeral component | | uncemented | cemented | partially cemented | cemented or
uncemented |
| Terminal sterilization | | Gamma | Gamma | Gamma | Gamma |
| Manufacturer | | Tornier | Tornier | Tornier | DePuy |
| K-number | | K100142 | K030941,
K041873,
K050316,
K061439,
K081059 | K082120 | K062250,
K071379,
K091751 |
9) Summary of technological characteristics
The technical characteristics (materials, design and sizing) of the new components of the Aequalis Reversed Shoulder Prosthesis are similar or identical to the predicate devices.
Image /page/6/Picture/7 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is designed with thick lines and has a slightly abstract, geometric appearance. The logo is black and white, with the 'T' and the hexagon both being black against a white background.
TORNIER S.A.S. 161, rue Lavoisier - Monthonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 3/ page 4
S.A.S. nu capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGI! SOCIAL : rue du Dayen Gosse - 38330 SAINT-ISMIER - FRANCE
7
K10014d #4/4
mplants Chirurgicaux
10) Non-clinical testing
Non-clinical testing was not necessary to determinate substantial equivalence between the new uncemented stems and new uncemented metaphysis of the Aequalis Reversed Shoulder Prosthesis and the cited predicate devices:
- The design of the new components of the Aequalis Reversed Shoulder Prosthesis (uncemented . stems and uncemented metaphyses) is identical to the design of predicate Aequalis Reversed Shoulder Prosthesis (K030941, K041873, K050316, K061439, and K081059) except for the addition of an HA coating.
- The raw material of the new components of the Aequalis Reversed Shoulder Prosthesis -(uncemented stems and uncemented metaphyses) is identical to the raw material of predicates Aequalis Reversed Fracture Shoulder Prosthesis (K082120) and Delta Xtend (K062250, K071379, and K091751).
- The coating material of the new components of the Aequalis Reversed Shoulder Prosthesis -(uncemented stems and uncemented metaphyses) is identical to the coating material of the predicate Aequalis Reversed Fracture Shoulder Prosthesis (K082120).
- The fixation method of the new humeral components of the Aequalis Reversed Shoulder Prosthesis is identical to the fixation method of the predicates Aequalis Reversed Fracture Shoulder Prosthesis (K082120) and Delta Xtend (K062250, K071379, and K091751).
11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new components of the Aequalis Reversed Shoulder Prosthesis to the cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- The new components of the Aequalis Reversed Shoulder Prosthesis are compared to the predicate devices.
- The new components of the Aequalis Reversed Shoulder Prosthesis have the same intended use as 1 the cleared predicate.
- Major technological characteristics are equivalent between the new components of the Aequalis • Reversed Shoulder Prosthesis and the predicate devices:
- Equivalence of general features l
- Equivalent means of fixation
- Equivalent materials -
.
- Equivalent surgical technique.
Therefore, in the light of the above information, the new components of the Aequalis Reversed Shoulder Prosthesis are found to be equivalent to the predicate devices.
Image /page/7/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is designed with a unique, almost tree-like structure, featuring a thick vertical line and two curved shapes on either side near the top. The logo is presented in black and white, with the 'T' appearing solid and the hexagon outlining it.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 4/ page 4
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAIN'T-ISMIER - FRANCE