(28 days)
Not Found
No
The summary describes a mechanical prosthetic device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a prosthetic replacement intended to relieve severe pain and disability in various joint diseases, and restore the shoulder joint to its best working condition, which are therapeutic goals.
No
The device is a prosthetic replacement system for the shoulder joint, designed to treat conditions like arthritis and fractures by restoring function and reducing pain, not to diagnose diseases or conditions.
No
The device description clearly describes a physical prosthetic shoulder system intended for surgical implantation, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint to relieve pain and disability caused by various conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description further reinforces that this is a prosthetic system for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the AEQUALIS Shoulder System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
The AEQUALIS Shoulder System is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
The SEQUALIS Shoulder System is intended to accomplish these goals. With the AEQUALIS Shoulder System the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease of injury. Through the AEQUALIS Shoulder System is primarily intended for use as a cemented total shoulder replacement system, it is equally useful as a hemi-shoulder. The modular nature of this system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present Device Modification submission corresponds to the addition of 3 long humeral stems to 3 Inc pressite 2010 stem/neck angle, with the same indications for use already covered by the previous 510(k) clearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, 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)
Not Found
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.
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
Surgical In
Summary of Safety and Effectiveness information Special 510(k) - AEQUALIS Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
- Device name Trade name: Common name: Classification name:
AEQUALIS Shoulder System Total-Shoulder System and Hemi-Shoulder System 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 S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mircille.lemervatornier.fr
- Classification Device class: Class II Classification panel: Orthopedic KWS Product code: $ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
5) Equivalent / Predicate device
AEQUALIS Shoulder system, TORNIER SA (K952928) Select Shoulder CoCr Humeral stem, Intermedics Orthopedics Inc, (K962315)
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 appearing to be a double "T" and the vertical line of the "T" extending to the bottom of the hexagon. The logo is black and white, with the "T" being black and the hexagon being white.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Phone : 33 (0)4 76 61 35 (0) Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
REGISTERED OFFICE : B.P. 11 - cue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
Page 1/ page 2
1
6) Device description
- Devel deseription conditions such as extensive soft tissue damage to the gleno-humeral joint, osteoarthritis, rheumatoid otheritis, traumatic arthritis, and osteonecrosis following severe trauma to the joint. The usual goal of such surgery is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The SEQUALIS Shoulder System is intended to accomplish these goals. With the AEQUALIS Shoulder System the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease of injury. Through the AEQUALIS Shoulder System is primarily intended for use as a cemented total shoulder replacement system, it is equally useful as a hemi-shoulder. The modular nature of this system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement.
The present Device Modification submission corresponds to the addition of 3 long humeral stems to 3 Inc pressite 2010 stem/neck angle, with the same indications for use already covered by the previous 510(k) clearance.
7) Materials
- The humeral implant is manufactured from titanium alloy (TA6V4) in accordance with ISO standard 5832-3 or in chromium-cobalt alloy (CrCo) according to ISO standard 5832-4, depending on models.
8) Indications
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatio disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.
Image /page/1/Picture/10 description: The image shows a logo with two stylized letters, 'T' and 'P', combined to form a single symbol. The 'T' is larger and forms the outer shape, while the 'P' is smaller and nestled within the 'T'. The entire symbol is enclosed within a hexagon, creating a clean and geometric design.
TORNIER S.A 161. rue Lavoisier 38330 MONTBONNOT FRANCE
Phone : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 (00 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
Page 2/ page 2
REGISTERED OFFICE : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to promote health, well-being, and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mrs. Mireille Lemery Regulatory Affairs & Quality Engineer TORNIER S.A. Zirst - 161, rue Lavoisier 38330 Montbonnot France
Re: K041339
Trade/Device Name: AEQUALIS Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: May 11, 2004 Received: May 20, 2004
Dear Mrs. Lemery:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosaly to tegains and the Medical Device Amendments, or to conniner of the 11th 11th 2011 de neces mat nave been recuire approval of a premarket approval application (PMA). and Costicule For (110) that as nov separal controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is oldssinod (600 above) and existing major regulations affecting your device can Inay be subject to subli additions, 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 i least be advised that I DTT 3785aanse over device complies with other requirements of the Act that I Dri has made a aved regulations administered by other Federal agencies. You must or any i cacial statutes and regations and and limited to: registration and listing (21 Comply with an the Not 810 crocations, 01); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quino) by the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your section 510(k) I his reter will anow you to begin maneting your as a read of your device to a legally premitsel notification. The PDA mining of casomation 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 If you desire specific advice for your de 1100 of Also, please note the regulation entitled, and Coniact the Office of Compuner an (est notification" (21CFR Part 807.97). You may obtain Misolallums by reference to premainters with the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milkersan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k); Device modification - Premarket Notification 510(k) AEQUALIS Shoulder System
Indications for Use
510(k) Number (if known): K041339
Device Name: AEQUALIS Shoulder System
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
The AEQUALIS Shoulder System is intended for cemented use only.
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K041339