(121 days)
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.
The Aequalis Shoulder System is intended to restore the shoulder joint to its best working condition and to reduce or eliminate pain. 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 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.
This document is a 510(k) premarket notification for a medical device modification, specifically the addition of a new glenoid system ("Tornier Glenoid") to the existing Aequalis Shoulder System. The primary purpose of this submission is to demonstrate "substantial equivalence" of the modified device to legally marketed predicate devices, not to establish new performance criteria through a study with the modified device.
Therefore, the document does not contain acceptance criteria and a study demonstrating the device meets these criteria in the typical sense of a novel device demonstrating efficacy or performance through clinical trials. Instead, it argues for equivalence based on similar design, materials, indications for use, and a limited set of non-clinical bench tests confirming that the modifications do not introduce new risks.
Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available due to the nature of a 510(k) submission:
1. Table of acceptance criteria and the reported device performance
This document does not present a table of specific numerical acceptance criteria (e.g., minimum tensile strength, maximum wear rate) and corresponding reported performance values for the new Tornier Glenoid. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, focusing on similarity rather than novel quantitative metrics.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use: Identical to predicate Aequalis and similar to Affiniti™ Shoulder Systems. | Met: "The intended use of the new Tornier Glenoid are identical to the intended use of predicates..." |
| Indications for Use: Identical to predicate Aequalis and similar to Affiniti™ Shoulder Systems. | Met: "The indications for use of the new Tornier Glenoid are identical to the indications for use of the predicate Aequalis System... and are very similar with the other predicate the Affiniti™ Shoulder System..." |
| Material Composition: Identical raw materials to predicate devices. | Met: "The raw materials of the new components of the Tornier Glenoid are identical to the raw materials of predicates Aequalis Shoulder System... and the Affiniti™ Shoulder System." |
| Fixation Method: Identical to predicate devices. | Met: "The fixation method of the new Tornier Glenoid is identical to the fixation method of the predicate components of the Aequalis Shoulder System... and the Affiniti Shoulder System." |
| Technological Characteristics: Equivalent general features, polyethylene thickness, materials, means of fixation, and prosthetic dimensions to predicate devices. | Met: "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." |
| Safety: Does not introduce new or higher risks compared to predicate devices. | Met: "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..." |
| Non-clinical performance: Satisfactory results from bench tests (Range of motion, preliminary testings of pegs, pull out & shear testings, subluxation and loosening tests). | Met: Bench tests were performed and results supported the conclusion of no new or higher risk. Specific numerical results are not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not explicitly stated as a "test set" in the context of a clinical study. The "test set" refers to the new Tornier Glenoid components that underwent non-clinical bench testing. The specific number of components tested for each bench test is not provided in this summary.
- Data provenance: The non-clinical testing was performed by Tornier S.A.S. in France. This is implied by the company's address and the nature of manufacturing and R&D activities. The data is prospective, generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is a 510(k) submission for a device modification, "ground truth" in the sense of clinical disease diagnosis or outcome for a test set of patients (as would be established by medical experts) is not part of the submission criteria. The "ground truth" here is adherence to design specifications, material standards, and performance in bench tests against established engineering principles, which would be managed by product development engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method among experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a physical medical device (shoulder prosthesis) modification, not an AI or imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing is based on:
- Established engineering standards and design specifications for prosthetic implants (implied by the bench testing, e.g., acceptable range of motion, pull-out strength).
- Material standards (e.g., ISO 5834-2 for UHMWPE, ISO 5832-7 for CoCr alloy).
- Performance of predicate devices, used as a basis for comparison to ensure the modified device performs similarly and safely in simulated conditions.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of machine learning. If "training set" is being reinterpreted as the data or knowledge base used to design and develop the device, it would encompass all prior design data, material science knowledge, and manufacturing experience for the Aequalis system and similar prostheses. However, this is not quantified in the document.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" in the machine learning sense. The design and validation of the device rely on established engineering principles, material science, and regulatory standards for medical device safety and performance. Manufacturing quality controls ensure that each produced device conforms to these established specifications.
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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
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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
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ાા વેળટ
10) Summary of technological characteristics
| Main features orsystem characteristics | TornierGlenoidSystem | AequalisShoulderSystem | AffinitiTMShoulderSystem |
|---|---|---|---|
| Materials | UHMWPE+CoCr | UHMWPE+CoCr | UHMWPE |
| Shape | Pear shape | Pear shape | Pear shape |
| Method of fixation | cemented | cemented | cemented |
| Sizes | 4 sizes (S, M, Land XL) for thepegged andkeeled glenoid | Function of therange: 3 to 6 sizesfor the peggedand keeledglenoid | 5 sizes(40, 44, 48, 52and 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 Shoulderreplacement | Total Shoulderreplacement | Total Shoulderreplacement |
| Terminal sterilization | Gamma | Gamma | Gamma |
| Manufacturer | Tornier | Tornier | Tornier Inc. |
| K-number | pending | K952928K994392K060209K063081 | K060988K103007 |
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
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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
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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
§ 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.”