(30 days)
No
The document describes a prosthetic shoulder system and its components, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is a prosthetic replacement indicated to relieve severe pain or significant disability caused by various degenerative pathologies and fractures, indicating a therapeutic purpose to alleviate symptoms and restore function.
No
The device is a prosthetic shoulder replacement system used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a prosthetic replacement system, which involves physical implants (humeral stems, humeral heads, glenoid components). This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a prosthetic replacement for the shoulder joint to relieve pain and disability caused by various conditions like arthrosis, fractures, and necrosis. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the components of a shoulder prosthesis (humeral stems, humeral heads, glenoid components) and their compatibility. This further confirms its nature as a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Aequalis Shoulder System and Aequalis Shoulder Fracture System are medical devices, specifically surgical implants, and not IVDs.
N/A
Intended Use / Indications for Use
Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):
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 Shoulder Fracture System
- . Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- o Revision surgery when other treatments or devices have failed.
Product codes
87 KWS
Device Description
The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems.
The Affiniti pegged glenoid components are available in sizes 40 - 56.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, glenohumeral joint, humeral head
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)
K994392, K003728, K012212, K032679, K060209, K952928, K980244, K012212, K041339, K043077, K060209, K060988
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
081707
p-1/2
TORNIT
JUL 1 7 2008
510(k) Summary
| 510(k) SPONSOR: | Tornier
100 Capital Drive, Suite 201,
Warsaw, IN 46582 |
|-------------------------------|---------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jeff Ondrla,
Vice President, Product Development
(574) 527-9951
JOndrla@Tornier.com |
| TRADE NAME: | , Aequalis Shoulder Fracture System and Aequalis Shoulder
System |
| COMMON NAMES: | Total shoulder prosthesis |
| CLASSIFICATION,
and CLASS: | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-
constrained cemented prosthesis; Class II |
| PRODUCT CODES: | 87 KWS |
PREDICATE DEVICES:
Aequalis Shoulder Fracture System: K994392, K003728, K012212, K032679 and K060209
Aequalis Shoulder System: K952928, K980244, K012212, K041339, K043077 and K060209
DVO (now Tornier) Total and Hemi Shoulder System: K060988
DEVICE DESCRIPTION:
The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems.
The Affiniti pegged glenoid components are available in sizes 40 - 56.
1
INDICATIONS FOR USE:
Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
81767
- · 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 Shoulder Fracture System
- . Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- o Revision surgery when other treatments or devices have failed.
BASIS FOR SUBSTANTIAL EQUIVALENCE:
The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tornier % Mr. Jeff Ondrla Vice President, Product Development 100 Capital Drive, Suite 201 Warsaw, IN 46582
JUL 1 7 2008
Re: K081707
Trade/Device Name: Aequalis Shoulder Fracture System and 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: June 13, 2008 Received: June 17, 2008
Dear Mr. Ondrla:
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 – Mr. Jeff Ondrla
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
081707
Indications for Use Statement
510(k) Number (if known): ___
Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):
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 a
- 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 Shoulder Fracture System
- Traumatic or pathologic conditions of the shoulder resulting in fracture of the . glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- Revision surgery when other treatments or devices have failed. ಂ
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Barbara Bucheld
Page1of1
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al. Restorative, and Neurological Devices
510(k) Number K081707