(180 days)
Not Found
No
The summary describes a mechanical shoulder prosthesis and its intended use and testing, with no mention of AI or ML technology.
Yes
The device is a prosthesis intended to replace shoulder joints to provide increased mobility and stability and to relieve pain, which aligns with the definition of a therapeutic device.
No
The device is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a non-constrained prosthesis consisting of a humeral stem and potentially a reversed insert, which are physical components intended for surgical implantation. This is a hardware 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 and Intended Use: The description clearly states that the Aequalis Fx2 is a prosthesis intended for the surgical replacement of shoulder joints. It is a physical implant used within the body.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information. The performance studies described are mechanical tests (pull out, torque, fatigue) on the device itself, not tests on patient samples.
Therefore, the Aequalis Fx2 is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the proximal humerus
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
-
Rheumatoid arthritis
-
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
-
Correction of functional deformity
-
Fractures of the proximal humerus
-
Traumatic arthritis
-
Revision of the devices if sufficient bone stock remains.
The reversed insert is permitted to be used in the transformation to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.
Notes:
- all components are single use.
- the humeral stem is for cemented use only.
- the all-poly glenoid components are intended for cemented use only.
- the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, HSD
Device Description
The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
The Aequalis Fx2 consists of:
in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; Or
-
in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis Reversed/Aequalis Reversed II glenoid implants.
The Aequalis Fx2 is intended for use as: -
traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
-
in case of bone defect in the proximal part of the humerus,
-
a replacement of shoulder joints in primary anatomic or in primary reverse,
-
a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. -
The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / Glenohumeral articulation
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, torque testing, and fatigue testing were performed.
- The aim of pull out and torque testing is to validate the locking mechanism between a metal part simulating an Aequalis Fx2 humeral stem and an UHMWPE simulating reversed insert.
- The aim of fatigue testing in anatomic configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in an anatomic configuration.
- The aim of fatigue testing in reversed configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in a reversed configuration after anatomic configuration.
Key results: The results of these tests demonstrate the equivalence between the Aequalis Fx2 and the predicate devices.
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.
K122698, K060209, K131231, K082120, K113069
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
TORNIER S.A.S. Maud Andriollo Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin FRANCE
Re: K141345
Trade/Device Name: Aequalis Fx2 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: October 28, 2014 Received: October 30, 2014
Dear Maud Andriollo:
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 – Maud Andriollo
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K141345
Device Name Aequalis Fx2
Indications for Use (Describe)
IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty. if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the proximal humerus
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
-
Rheumatoid arthritis
-
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
-
Correction of functional deformity
-
Fractures of the proximal humerus
-
Traumatic arthritis
-
Revision of the devices if sufficient bone stock remains.
The reversed insert is permitted to be used in the transformation to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.
Notes:
- all components are single use.
- the humeral stem is for cemented use only.
- the all-poly glenoid components are intended for cemented use only.
- the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Image /page/3/Picture/0 description: The image shows the word "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, are the words "Implants Chirurgicaux". The words are stacked on top of each other and centered.
510 (k) Summary of Safety and Effectiveness information Traditional 510(k) Premarket – Aequalis Fx2
Date: November, 14th 2014
| 1) Device name | |
|---|---|
| Trade name: | Aequalis Fx2 |
| Common name: | Shoulder Prosthesis |
| Classification name: |
- · Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) and are classified by the Orthopedic Devices Panel
- · Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code PHX)
- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under . CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel
2) Submitter :
TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
3) Company contact :
Tornier Mrs Maud Andriollo Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail:maud.andriollo@tornier.com
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWS, PHX, HSD |
5) Equivalent / Predicate device : Aequalis Ascend Flex Shoulder System, TORNIER SAS, K122698
Image /page/3/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by geometric shapes, creating a modern and abstract design. The hexagon and the 'T' are both in a light blue or lavender color, contrasting with the white background. The logo appears clean and simple, suitable for a tech company or a brand with a focus on innovation.
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
4
Image /page/4/Picture/0 description: The image contains the name "TORNIER" in large, bold, blue font. Below that, in a smaller, bold, blue font, is the phrase "Implants Chirurgicaux". The text appears to be a logo or brand name for a company that produces surgical implants.
Aequalis Shoulder Fracture System, TORNIER SAS, K060209, K131231 Aequalis Reversed Fracture Shoulder Prosthesis, TORNIER SAS, K082120, K131231 Comprehensive Reverse Shoulder System, BIOMET, K113069
6) Device description :
The Aequalis Fx2 is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
The Aequalis Fx2 consists of:
in an anatomic configuration, a humeral stem compatible with Flex Shoulder System humeral heads ; । Or
-
in a reversed configuration, a humeral stem and a reversed insert, compatible with Aequalis । Reversed/Aequalis Reversed II glenoid implants.
The Aequalis Fx2 is intended for use as: -
। traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures,
-
in case of bone defect in the proximal part of the humerus, ।
-
a replacement of shoulder joints in primary anatomic or in primary reverse, ।
-
a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. -
The Aequalis Fx2 also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
7) Materials :
The humeral stem is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO 5832-3 and coated with hydroxylapatite (HAP) in accordance with ASTM standard F-1185 or ISO 13779-2.
The reversed insert is manufactured from UHMWPE according to ISO standard 5834-2 and titanium alloy (Ti6Al4V) in accordance with ISO 5832-3.
8) Indications :
IN ANATOMIC:
The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain -
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) ।
- Correction of functional deformity ।
- Fractures of the proximal humerus ।
- -Traumatic arthritis
- Revision of other devices if sufficient bone stock remains. -
Image /page/4/Picture/26 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The color of the logo is a light shade of blue or lavender, providing a soft and clean aesthetic. The hexagon shape provides a clear border for the logo.
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
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Image /page/5/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font on the top line. The words "Implants Chirurgicaux" are in a smaller, bold, blue font on the second line.
IN REVERSE:
The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis ।
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) ।
- । Correction of functional deformity
- Fractures of the proximal humerus -
- -Traumatic arthritis
- Revision of the devices if sufficient bone stock remains. ।
The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle.
Notes:
- all components are single use. ।
- the humeral stem is for cemented use only. -
- the all-poly glenoid components are intended for cemented use only. ।
- । the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- the humeral head diameters 37 and 39mm must be utilized only with the stem with a small metaphysis. -The humeral head must cover completely the stem metaphysis.
Image /page/5/Picture/16 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The hexagon and the 'T' are both colored in a light blue or lavender hue. The logo is simple and clean, suggesting a focus on design and possibly technology or innovation.
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
6
Image /page/6/Picture/0 description: The image displays the word "TORNIER" in large, bold, blue font. Below this, the words "Implants Chirurgicaux" are written in a smaller, blue font. The text appears to be a logo or heading, possibly for a medical or surgical company specializing in implants.
9) Summary of technological characteristics
Table 1: Main features comparison
| Main features or
system characteristics | | Aequalis Fx2 | Aequalis Ascend Flex
Shoulder System | Aequalis Shoulder
Fracture System | Aequalis Reversed
Fracture Shoulder
Prosthesis | Comprehensive Reverse
Shoulder System |
|--------------------------------------------|--------------------|-----------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|------------------------------------------|
| Material | Stem | Titanium + HAP | Titanium + Ti Plasma
Spray | Titanium + HAP | Titanium + HAP | Titanium + Ti Porous
Plasma spray |
| | Reversed
Insert | UHMWPE + Titanium | UHMWPE + Titanium | NA | UHMWPE | Titanium + UHMWPE |
| Standard | Stem | ASTM F136 / ISO 5832-3 | ASTM F136 / ISO 5832-3 | ASTM F136 / ISO 5832-3 | ASTM F136 / ISO 5832-3 | unknown |
| | Coating | ASTM F1185 | ASTM F1580 | ASTM F1185 | ASTM F1185 | ASTM F1580 |
| | Reversed
Insert | ISO 5834-2 + ISO 5832-3 | ISO 5834-2 + ISO 5832-3 | NA | ISO 5834-2 | unknown |
| Stem fixation | | Cemented on distal part
Uncemented on proximal
part | Cemented or uncemented | Cemented on distal part
Uncemented on proximal
part | Cemented use | Cemented or uncemented |
| Stem length | | 90; 130; 170; 210 mm | 66; 70; 74; 78; 82; 86; 88;
90; 93; 94; 98; 104; 109;
115; 120; 125 mm | 130; 170; 180; 210 mm | 130; 170; 180; 210 mm | 55; 83; 122; 194 mm |
| Diameter of reversed
insert | | 36mm, 42mm
Thickness 6; 9; 12 mm | 36mm, 42mm
Thickness 6; 9 mm | NA | 36mm, 42mm
Thickness 6; 9; 12mm | 31mm, 36mm, 41mm |
| Terminal sterilization | | Yes | Yes | Yes | Yes | Yes |
| Manufacturer | | Tornier | Tornier | Tornier | Tornier | Biomet |
| K-number | | Pending | K122698 | K060209, K131231 | K082120, K131231 | K113069 |
Image /page/6/Picture/4 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light purple or lavender color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clean, geometric border around the 'T', further emphasizing the logo's contemporary design. The background is plain white, which makes the logo stand out.
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
7
Image /page/7/Picture/0 description: The image shows the words "TORNIER Implants Chirurgicaux" in a dark blue font. The word "TORNIER" is in a larger font than the words "Implants Chirurgicaux". The words are stacked on top of each other, with "TORNIER" on top and "Implants Chirurgicaux" on the bottom. The background is white.
The design, the indication for use, the manufacturing principle, the method of fixation of the stem, the packaging and the sterilization process of the Aequalis Fx2 are identical or equivalent to the predicate devices.
10) Non-clinical testing
Pull out, torque testing, and fatigue testing were performed.
- The aim of pull out and torque testing is to validate the locking mechanism between a metal part simulating an Aequalis Fx2 humeral stem and an UHMWPE simulating reversed insert.
- -The aim of fatigue testing in anatomic configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in an anatomic configuration.
- -The aim of fatigue testing in reversed configuration is to evaluate the fatigue strength of the Aequalis Fx2 implant in a reversed configuration after anatomic configuration.
The results of these tests demonstrate the equivalence between the Aequalis Fx2 and the predicate devices.
11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the Aequalis Fx2 to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:
- -The Aequalis Fx2 is compared to the predicate devices.
- The Aequalis Fx2 has the same intended use as the cleared predicates. -
- -Major technological characteristics are equivalent between the Aequalis Fx2 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 Aequalis Fx2 is 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 rendered in a light blue or lavender color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear, defined border for the logo, making it stand out.
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