(121 days)
No
The document describes a prosthetic shoulder system and its components, focusing on materials, design, and mechanical testing. There is no mention of AI or ML technology.
Yes
The device is described as a prosthetic replacement intended to relieve severe pain or significant disability, restore the shoulder joint to its best working condition, and reduce or eliminate pain, all of which align with the definition of a therapeutic device.
No
Explanation: The device is a prosthetic replacement for the shoulder joint, designed to restore function and reduce pain, not to diagnose a condition.
No
The device description clearly states it consists of a humeral stem, humeral head, and glenoid components, which are physical implants for shoulder replacement surgery. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Aequalis Shoulder System is a prosthetic replacement intended to restore the shoulder joint. It consists of physical implants (humeral stem, humeral head, glenoid component) that are surgically implanted into the body.
- Intended Use: The intended use describes the conditions for which the device is indicated, all of which relate to physical problems with the shoulder joint requiring surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
- -Displaced 4-part upper humeral fracture
- Humeral head fracture -
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.
Product codes
KWS
Device Description
The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists in a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Acqualis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder.
The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present device modification submission consists in the addition of a new glenoid system, named Tornier Glenoid, to the current cleared model. The Tornier Glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and Cortil oct 14 peg available in a variety of sizes.
The Tornier Glenoid has been designed to be compatible with the Aequalis, Affiniti and Ascend humeral head systems in certain combinations.
The new Tomier Glenoid completes the Tornier range of glenoid implants.
Tornier Glenoid component is intended for cemented use only.
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
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 not necessary to determinate substantial equivalence between the new Tornier Glenoid and the cited predicate devices regarding:
-
The indications for use of the new Tornier Glenoid are identical to the indications for use of the predicate Aequalis System (K952928, K994392, K060209 and K063081) and are very similar with the other predicate the AffinitiTM Shoulder System (K060988, K103007).
-
The intended use of the new Tornier Glenoid are identical to the intended use of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the AffinitiTM Shoulder System (K060988, K103007).
-
The raw materials of the new components of the Tornier Glenoid are identical to the raw materials of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the AffinitiTM Shoulder System (K060988, K103007).
-
The fixation method of the new Tornier Glenoid is identical to the fixation method of the predicate components of the Aequalis Shoulder System (K952928, K994392, K060209 and K063081 ) and the Affiniti Shoulder System (K060988, K103007).
The modifications made to the proposed Aequalis Shoulder System, addition of a new Tomier Glenoid range, were verified and validated by performing non-clinical testing: -
Bench test:
- · Range of motion
- Preliminary testings peripheral and central pegs design influence of cement compaction & cement layer thickness
- Pull out & shear testings on Tornier Glenoids
- Subluxation and loosening tests on glenoid components
The results of those evaluations allow us to conclude that the proposed new Tornier Glenoid described in this submission does not induce any new or higher risk compared to the predicate devices and therefore both devices (proposed and predicate) are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K952928, K994392, K060209, K063081, K060988, K103007
Reference Device(s)
Not Found
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
11 902 Implants Chirr
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification -- Aequalis Shoulder System
Date prepared: October 14th, 2011
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | Aequalis Shoulder System |
|---|---|
| Common name: | Total shoulder prosthesis |
| Classification name: | 888.3660 Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis |
2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
3) Applicant
Tornier, Inc. 7701 France avenue South Edina MN 55345 - USA
4) 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
5) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWS |
6) Equivalent / Predicate device
Aequalis Shoulder System, Tornier, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007
Image /page/0/Picture/17 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 part of the "T" appearing to be a separate piece. The hexagon provides a border around the "T", making it stand out. The logo is simple and monochromatic.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Tel. : 33 (0)4 76 61 35 00
Section 5 - Page 1/ page 4
1
7) Device description
The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists in a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Acqualis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder.
The modular nature of the system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present device modification submission consists in the addition of a new glenoid system, named Tornier Glenoid, to the current cleared model. The Tornier Glenoid system is a comprehensive offering that includes a variety of anchorage options such as a keel, standard peg and Cortil oct 14 peg available in a variety of sizes.
The Tornier Glenoid has been designed to be compatible with the Aequalis, Affiniti and Ascend humeral head systems in certain combinations.
The new Tomier Glenoid completes the Tornier range of glenoid implants.
Tornier Glenoid component is intended for cemented use only.
8) Materials
The glenoid implant is manufactured of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2 and from chromium cobalt alloy (radio wire) according to ISO 5832-7.
9) Indications for use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic .
- arthrosis. Primary or secondary necrosis of the humeral head
- -Displaced 4-part upper humeral fracture
- Humeral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable. Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.
Image /page/1/Picture/19 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of thick, geometric lines, giving it a modern and somewhat industrial appearance. The logo is black and white, with the "T" appearing to be slightly raised or embossed within the hexagon.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00
Section 5 - Page 2/ page 4
2
ાા વેળટ
10) Summary of technological characteristics
| Main features or
system characteristics | Tornier
Glenoid
System | Aequalis
Shoulder
System | AffinitiTM
Shoulder
System |
|--------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------|
| Materials | UHMWPE
+
CoCr | UHMWPE
+
CoCr | UHMWPE |
| Shape | Pear shape | Pear shape | Pear shape |
| Method of fixation | cemented | cemented | cemented |
| Sizes | 4 sizes (S, M, L
and XL) for the
pegged and
keeled glenoid | Function of the
range: 3 to 6 sizes
for the pegged
and keeled
glenoid | 5 sizes
(40, 44, 48, 52
and 56) |
| Anchorage | 4 pegs or keel | 4 pegs or keel | 4 pegs or keel |
| Polyethylene thickness | 4mm | 2 to 4mm | 4mm |
| Indications for use | Total Shoulder
replacement | Total Shoulder
replacement | Total Shoulder
replacement |
| Terminal sterilization | Gamma | Gamma | Gamma |
| Manufacturer | Tornier | Tornier | Tornier Inc. |
| K-number | pending | K952928
K994392
K060209
K063081 | K060988
K103007 |
The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of the new Tornier Glenoid are similar or identical to the predicate devices.
11) Non-clinical testing
Non-clinical testing was not necessary to determinate substantial equivalence between the new Tornier Glenoid and the cited predicate devices regarding:
- The indications for use of the new Tornier Glenoid are identical to the indications for use of the predicate Aequalis System (K952928, K994392, K060209 and K063081) and are very similar with the other predicate the Affiniti™ Shoulder System (K060988, K103007).
- ・ The intended use of the new Tornier Glenoid are identical to the intended use of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the Affiniti™ Shoulder System (K060988, K103007).
- The raw materials of the new components of the Tornier Glenoid are identical to the raw materials of predicates Aequalis Shoulder System (K952928, K994392, K060209 and K063081) and the Affiniti™ Shoulder System (K060988, K103007).
Image /page/2/Picture/9 description: The image shows a logo with two letters, 'T' and 'P', arranged in a stylized manner. The 'T' is positioned above the 'P', and both letters are designed with thick, bold lines. The logo is enclosed within a hexagon shape, which provides a border around the letters. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution image.
Tél. : 33 (0)4 76 61 35 00 TORNIEK S.A.S. 161. rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
Section 5 - Page 3/ page 4
3
Image /page/3/Picture/0 description: The image shows the word "TORNIER" in large, bold letters. Below that, the words "Implants Chirurgicaux" are printed in a smaller font. Above the word "TORNIER", there is a handwritten number, "K111902". The image appears to be a logo or label for a medical device company specializing in surgical implants.
-
The fixation method of the new Tornier Glenoid is identical to the fixation method of the . predicate components of the Aequalis Shoulder System (K952928, K994392, K060209 and K063081 ) and the Affiniti Shoulder System (K060988, K103007).
The modifications made to the proposed Aequalis Shoulder System, addition of a new Tomier Glenoid range, were verified and validated by performing non-clinical testing: -
Bench test:
- · Range of motion
- Preliminary testings peripheral and central pegs design influence of cement o compaction & cement layer thickness
- 0 Pull out & shear testings on Tornier Glenoids
- Subluxation and loosening tests on glenoid components 0
The results of those evaluations allow us to conclude that the proposed new Tornier Glenoid described in this submission does not induce any new or higher risk compared to the predicate devices and therefore both devices (proposed and predicate) are substantially equivalent.
12) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of the new Tornier Glenoid to the already 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 Tornier Glenoid are compared to the predicate devices.
- The Tomier Glenoid have the same intended use as the Aequalis shoulder System and the . Affiniti™ Shoulder System are very similar indications for use.
- -Major technological characteristics are equivalent between the Tornier Glenoid and the predicate devices:
- Equivalence of general features •
- Equivalent polyethylene thickness -
- . Equivalent materials
- Equivalent means of fixation -
- Equivalent prosthetic dimensions .
Therefore, in light of the above information, the company believes that the Tornier Glenoid may be cleared via the 510(k) notification process for use as total shoulder prosthesis.
Image /page/3/Picture/20 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with the top bar extending beyond the vertical stem. The logo is black and white, with the 'T' being the most prominent feature.
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
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tornier, Inc. % Ms. Severine Bonneton Regulatory Affairs Specialist 161 Rue Lavoisier Montobonnot, Saint-Ismier France 38334
NOV - 3 2011
Re: K111902
- Trade/Device Name: Aequalis Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
- Regulatory Class: Class II Product Code: KWS Dated: October 14, 2011 Received: October 17, 2011
Dear Ms. Bonneton:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
Page 2 - Mrs. Severine Bonneton
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Erin P. Keith
So Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
KI 1902 510(k) Number (if known):
Device Name: Aequalis Shoulder System
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
- -Displaced 4-part upper humeral fracture
- Humeral head fracture -
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stem is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use.
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)
Chas to AXM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Tornier 510(k) Number _ Page 1 of 1