(30 days)
Not Found
Not Found
No
The summary describes a modification to a prosthetic device by adding a new material for the humeral head. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is a prosthetic replacement for the shoulder joint, which functions as a replacement for a damaged body part rather than directly providing therapy.
No
The device is a prosthetic replacement for the shoulder joint, used to relieve pain and disability in various conditions. It describes the materials and manufacturing of an implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a prosthetic replacement, which is a physical implant made of Cobalt-Chromium-Molybdenum Alloy. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a joint to relieve pain and disability caused by various conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a prosthetic replacement consisting of a humeral head, stem, and glenoid component. These are physical implants.
- 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, 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
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 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The present Device Modification submission corresponds to the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy according to the standard ISO 5832-12 to the previous range with the same indications for use already covered by the previous 510(k) clearance. The hunteral stem and the glenoid component are unchanged.
The manufacturing methods, intended use, packaging and sterilization of the subjected device are identical to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): 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.
Not Found
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
AUG 1 5 2001
K0122/2
Special 510(k): Device modification - Premarket Notification 510(k AEQUALIS Shoulder System
| Summary of Safety and Effectiveness Information | Aequalis Shoulder System |
|---|---|
| Special 510(k): Device modification | Tornier S.A.S. |
| Premarket Notification, Section 510(k) |
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
Device name 1)
AEQUALIS Shoulder System Trade name: Total-Shoulder System and Hemi-Shoulder System Common name: - Shoulder joint, metal/polymer semi-constrained cemented prosthesis Classification name:
2) Manufacturer
Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
3) Classification
$ 888.3660 Shoulder joint, metal/polymer semi-constrained cemented prosthesis.
| Classification panel: | Orthopedic |
|---|---|
| Product code: | 87 KWS |
| Device class: | Class II |
4) Device description :
The present Device Modification submission corresponds to the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy according to the standard ISO 5832-12 to the previous range with the same indications for use already covered by the previous 510(k) clearance. The hunteral stem and the glenoid component are unchanged.
The manufacturing methods, intended use, packaging and sterilization of the subjected device are identical to the predicate device.
5) Indications :
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, theumatoid, or traumatic disesse of the glenohumeral head fracture; displaced 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
6) Materials :
The stem is made from Cobalt Chromium alloy according to ISO 5832-4. The humeral head is available in both Cobalt-Chromium alloy according to ISO 5832-7 and ISO 5832-12. The glenoid components are produced from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO 5834-2, with a small cobalt-chrome pin included as an opaque radiographic marker.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into the design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2001
Ms. Irene Gosset Regulatory Affairs Tornier S.A. 161. rue Lavoisier 38330 Montbonnot France
Re: K012212
Trade/Device Name: Aequalis Shoulder System Regulation Number: 888.3660, 888.3690 Regulatory Class: I Product Code: KWS, HSD Dated: July 10, 2001 Received: July 16, 2001
Dear Ms. Gosset:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Irene Gosset
This letter will allow you to begin marketing your device as described in your 510(k) premarket I nis lotter will and hy your ding of substantial equivalence of your device to a legally marketed nvellicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
hheeeerfor
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
3
Page 1 of of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
AEQUALIS Shoulder System Device name:
Indication 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 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
B. Mitchell Womack
(Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number_(D
Prescription use
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
Tomier S.A.
S