(34 days)
Not Found
No
The document describes a mechanical prosthetic device for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a prosthetic replacement for the shoulder joint, intended to relieve pain and disability caused by various pathologies, including degenerative conditions and fractures. Restoring function and reducing pain are therapeutic goals.
No
This device is a prosthetic replacement system for the shoulder joint, intended to relieve pain and disability, not to diagnose a condition.
No
The device description clearly describes a physical implantable medical device (shoulder replacement system) with various components (glenoid components, fracture stem). It does not mention any software component as the primary or sole function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a prosthetic replacement for the shoulder joint to relieve pain and disability caused by various conditions and fractures. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a shoulder replacement system designed to restore the function of the shoulder joint. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
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
The Aequalis Shoulder Fracture System & Aequalis Shoulder System are indicated for prosthetic replacement to relieve severe pain or significant disability caused by:
AEQUALIS Shoulder Range (except AEQUALIS for Fracture):
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and 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.
AEQUALIS for Fracture:
- 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.
- Revision surgery when other treatments or devices have failed.
Product codes
KWS
Device Description
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis 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 hemiarthrosplasty to a total shoulder replacement.
The present submission corresponds to the following modifications:
- addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System,
- addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, glenohumeral 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K952928, K041339, K043077, K994392, K003728, K032679
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.”
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MAR 2 2006
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Implants Chirurgicaux
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification – Aequalis Shoulder Fracture System Aequalis Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
- Device name Aequalis Shoulder Fracture System & Aequalis Shoulder System Trade name: Common name: Hemi or Total Shoulder Prosthesis Classification name: & 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis
2) Submitter
Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
3) Company contact
Tornier Mrs Mireille Lémery Regulatory affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille.lemery@tornier.fr
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
- Equivalent / Predicate device For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339, K043077 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679, K043077
For the AEQUALIS Shoulder System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339, K043077
Image /page/0/Picture/14 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 part of the 'T' appearing to be a separate element resting on the vertical line. The hexagon provides a border around the 'T', giving the logo a defined shape.
TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier - Montbonnot Fax : 33 (0)4 76 61 35 33 38334 SAINT-ISMIER CEDEX FRANCE
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
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SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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060209
p.2/2
6) Device description
The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis 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 hemiarthrosplasty to a total shoulder replacement.
The present submission corresponds to the following modifications:
- addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System,
- addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.
7) Materials
The humeral implant is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO standard 5832-3 or in chromium-cobalt alloy (CrCo) according to ISO standard 5832-7, ISO standard 5832-12 or ISO standard 5832-4. The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.
The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.
8) Indications
AEQUALIS Shoulder Range (except AEQUALIS for Fracture)
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies : arthrosis, theumatoid arthritis, post-traumatic arthrosis. Primary and secondary 1 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. ।
AEQUALIS for Fracture:
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. Revision surgery when other treatments or devices have failed.
Image /page/1/Picture/21 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by a vertical line with a horizontal bar at the top, and it appears to be enclosed within a shield-like shape. The logo has a textured or slightly rough appearance, possibly indicating it's a scanned image or a design with a hand-drawn aesthetic. The hexagon provides a clear, geometric border for the central design.
Tél. : 33 (0)4 76 61 35 00 TORNIER S.A.S. Fax : 33 (0)4 76 61 35 33 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
Page 2/ page 2
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2006
Tornier S.A. C/O Mrs. Mireille Lemery Regulatory Affairs Manager 161, Rue Lavoisier- Montbonnot 38334 Saint Ismier Cedex France
Re: K060209
Trade/Device Name: Aequalis Shoulder Fracture System & 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: January 25, 2006 Received: January 31, 2006
Dear Mrs. Lemery:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 -- Mrs. Mireille Lemery
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Helena Lumer as
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Aequalis Shoulder Fracture System Aequalis Shoulder System
Indications For Use:
AEOUALIS Shoulder Range (except AEQUALIS for Fracture):
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 and 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. -
AEQUALIS for Fracture:
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.
Revision surgery when other treatments or devices have failed.
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)
Hulut
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_