(108 days)
No
The summary describes a mechanical shoulder replacement system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to relieve or eliminate pain and replace the natural glenoid and parts of the shoulder joint, which are therapeutic actions.
No
Explanation: The device description clearly states it is a "total shoulder replacement system" for relieving or eliminating pain from traumatic or pathologic conditions of the shoulder. It is an implant used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "total shoulder replacement system" and mentions "addition of a long stem," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant used to replace parts of the shoulder joint. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is to treat traumatic or pathologic conditions of the shoulder resulting in fracture, specifically by replacing the glenohumeral joint. This is a treatment and surgical intervention, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a medical device used for surgical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
KWS
Device Description
The usual goal of total shoulder repace nem ae or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid incelled to accomplish theor goals. The a 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 them-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthrosplasty to a total shoulder replacement.
The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder 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, K994392, K003728, K002683
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
DEC 1 5 2003
Implants Chirt
Summary of Safety and Effectiveness information Special 510(k) - AEQUALIS Shoulder Fracture System K032679
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
- Device name Trade name: Common name: Classification name:
AEQUALIS Shoulder Fracture 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.lemery@tornier.fr
4) Classification
Class II Device class: Classification panel: Orthopedic KWS Product code: § 888.3660 Shouldcr joint metal/polymer semi-constrained cemented prosthesis.
5) Equivalent / Predicate device
AEQUALIS Shoulder system, TORNIER SA (K952928) AEQUALIS Shoulder Fracture system, TORNIER SA (K994392, K003728) Modular Shoulder System, Wright Medical Technology Inc (K002683)
Image /page/0/Picture/16 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and black, with a unique design where the horizontal bar at the top is slightly curved and extends beyond the vertical stem. The hexagon is outlined in black and provides a geometric border for the letter.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 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
Page 1/ page 2
SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
1
PAGE 2 of 2
Implants Chirurgicau
6) Device description
- Device descriptiou I lie usual goal of total shoulder repace nem ae or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid incelled to accomplish theor goals. The a 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 them-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthrosplasty to a total shoulder replacement.
The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.
7) Materials
- Materials
The stem is made of Titanium alloy (6Al-4V-Ti) according to ISO 5832-3. It is grit-blasted on its proximal The send is made of Thankin and of Cobalt-Chromium alloy according to ISO 5832-7 or ISO 5832-12.
8) Indications
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.
Page 2/ page 2
Image /page/1/Picture/10 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is composed of thick, bold lines and has a slightly geometric design. The hexagon provides a border around the letter, creating a distinct and recognizable emblem.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 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
SIFGE SOCIAL : B.P. 11 - 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEC 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mireille Lémery Regulatory Affairs and Quality Engineer Tornier S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot FRANCE
Re: K032679 Trade/Device Name: AEQUALIS Shoulder Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: November 14, 2003 Received: November 17, 2003
Dear Ms. Lémery:
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 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.
3
Page 2 - Ms. Mireille Lémery
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
b. Mark McMillan
'elia 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
510(k) Number (if known): K032679
AEQUALIS Shoulder Fracture System Device name:
Indication for use:
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II' NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for Mark N. Mellars | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number: K032679 |
| Prescription use | ✓ | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| ------------------ | ------------------------------------------------------------------- | ---- | ----------------------------- |
(Per 21 CFR 801.109) (Optional format 1-2-96)