(577 days)
Not Found
No
The summary describes a standard shoulder prosthesis made of titanium and cobalt chromium alloys, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is a prosthesis (Shoulder Prosthesis) intended to treat various medical conditions such as osteoarthritis, rheumatoid arthritis, and severe joint pain, ultimately improving a patient's quality of life by replacing defective joints. These are all therapeutic actions.
No
Explanation: The device, the Æqualis® Shoulder Prosthesis, is an implant used to replace or revise shoulder joints due to various disorders, and its purpose is therapeutic (to restore function and reduce pain), not diagnostic.
No
The device description explicitly states the device is a shoulder prosthesis made from titanium alloy and used with humeral heads made of cobalt chromium alloy steel, 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 medical 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 description clearly states that the device is a shoulder prosthesis, which is an implantable medical device used to replace a damaged shoulder joint.
- Intended Use: The intended use describes the conditions for which the prosthesis is used to treat, all of which relate to the physical structure and function of the shoulder joint.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.
Product codes
87HSD, 87KWS
Device Description
Materials. The specific material used in the Equalis® Shoulder Prosthesis is marked on the packaging. The press fit Æqualis® Shoulder Prosthesis is made from titanium alloy (TA6V4, titanium alloy in accordance with standard ISO 5832-3) and is used with humeral heads made of cobalt chromium alloy steel. This provides material compatibility with the existing line of Equalis® Shoulder implant humeral heads.
The use of the Æqualis® Shoulder Prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus of the shoulder and may be performed only by a gualified surgeon. The surgeon must operate in accordance with current information on the state of scientific progress and the art of surgery.
Storage and handling. The prosthetic components must be handled and stored with care in accordance with the provisions of standard ISO 8828. The implants must be stored in their sealed packaging of origin.
Packaging and sterilization. The implants are supplied sterilized (gamma radiation). The expiration date for sterilization must be checked. Only those products implanted before the end of the valid shelf-life may be considered sterile. The packaging and labeling must be checked for integrity. Reject any implant if the packaging shows any damage or has been previously opened. The opening instructions are written on the packaging. Every precaution must be taken to ensure sterility when opening the packaging of the implant and when inserting it.
Instrumentation. Specialized instruments are required to properly implant the Algualis® Shoulder Prosthesis system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon
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)
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
AUG 23 1999
immary of Safety and
ctiveness Information remarket Notification, Section 510(k)
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
Device Name: 1.
| Trade Name: | Æqualis® Shoulder Prosthesis |
|---|---|
| Common Name(s): | Press fit hemi-shoulder, when used without glenoid |
| Press fit total shoulder, when used with glenoid | |
| Classification Name(s): | Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis. |
| And | |
| Shoulder joint metal/polymer semi-constrained cemented prosthesis. |
Establishment Name & Registration Number: 2.
| Name: | Tornier S.A |
|---|---|
| Number: | 8020756 |
Classification: 3.
$ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the humerus and to be fixed without bone cement (888.3027). This device is not intended for biological fixation. (b) Classification. Class II.
And, when used as a total shoulder implant using a glenoid component,
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 ultrahigh molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See 8888.3.
| Device Class: | Class II & Class III, as above |
|---|---|
| Classification Panel: | Orthopaedic |
| Product Code: | 87HSD & 87KWS respectively |
1
4
Company Contact: 4.
ﺗﻮ
Ms. Patricia Abraham, Marketing Manager Tornier, S.A. B.P. 11 - rue Doyen Gosse 38330 - Saint Ismier France 011.334.7652.8000 011.334.7652.0673 - fax
5. Special Controls:
Special Controls do not apply to this device.
6. Substantially Equivalent Device(s):
Aqualis® Shoulder System (cemented), Tornier, S.A., K952928 Biomet Biomodular®, Biomet, Inc., K872454 Neer II®, Zimmer, Inc., K790987
7. Indications for use:
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.
8. Labeling
Federal (United States) Law restricts this device to sale by or on the order of a physician.
Known contra-Indications to dale. Acute or chronic infectious diseases of any etiology and localization, unsuitable or insufficient bone support preventing proper anchoring of the prosthesis, neuromuscular or psychiatric disorders which might jeopardize fixation and postoperative care, bone immaturity, known allerqy to one of the materials, obesity, pregnant women.
Dislocation, infection, early or late loosening, Side-effects and possible complications. neuropathies, cardiovascular disorders, tissue reaction, complications associated with wear of the prosthetic components, changes in dimensions of the operated limb, breakage of the component as a result r of changes or abnormal activity, and a reduction in the range of motion. Sonic complications may be accelerated by excessive weight gain on the part of the patient. Sonic side-effects may require a revision of the involved prosthesis. Some complications and side-effects may stem from a lack of awareness of the precautions for use mentioned below.
Warnings and cautions. Never re-use an implant, even if it appears in perfect condition.
Pre-operatively. The surgeon must be fully conversant with all the aspects of the surgical technique and know the indications and contra-indications of this type of implant. The surgeon must have acquainted himself before the operation with the specific operative technique of the product which is available from the manufacturer. As part of the pre-operative examination, the surgeon must check that no biological, biomechanical or other factors are present that will affect the correct conduct of the operation and the postoperative period. An appropriate range of sizes must be available at the time of the operation. Check that the implant has not suffered any deterioration.
2
Per-operatively. The correct selection of the type and size of the implant appropriate to the patient and the positioning of the implant are extremely important. The functional surfaces of the implants must not suffer any damage, shock, abrasion or other deterioration.
Post-operatively. Patients must be informed by the surgeon of the precautions they must take in everyday life to quarantee the maximum implant service life. It is recommended that a regular postoperative follow-up is undertaken to detect early signs of wear loosening of the Prosthesis, etc., and to consider the action to be taken, Normal wear of the implant in respect of the state of knowledge at the time of its design cannot in any way be considered to constitute a dysfunction or a deterioration in the characteristic of the implant. A suitable rehabilitation program must be designed and implemented. See Appendix I for samples of labeling and instructions for use.
8. Description of the Device:
Materials. The specific material used in the Equalis® Shoulder Prosthesis is marked on the packaging. The press fit Æqualis® Shoulder Prosthesis is made from titanium alloy (TA6V4, titanium alloy in accordance with standard ISO 5832-3) and is used with humeral heads made of cobalt chromium alloy steel. This provides material compatibility with the existing line of Equalis® Shoulder implant humeral heads.
The use of the Æqualis® Shoulder Prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus of the shoulder and may be performed only by a gualified surgeon. The surgeon must operate in accordance with current information on the state of scientific progress and the art of surgery.
Storage and handling. The prosthetic components must be handled and stored with care in accordance with the provisions of standard ISO 8828. The implants must be stored in their sealed packaging of origin.
Packaging and sterilization. The implants are supplied sterilized (gamma radiation). The expiration date for sterilization must be checked. Only those products implanted before the end of the valid shelf-life may be considered sterile. The packaging and labeling must be checked for integrity. Reject any implant if the packaging shows any damage or has been previously opened. The opening instructions are written on the packaging. Every precaution must be taken to ensure sterility when opening the packaging of the implant and when inserting it.
Instrumentation. Specialized instruments are required to properly implant the Algualis® Shoulder Prosthesis system.
9. Cleaning/Sterilization/Re-sterilization:
The implantable product is supplied sterile from the manufacturer. The device may not be secondarily cleaned or resterilized. Once the product packaging is opened or damaged, the product is no longer considered sterile. All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging renders the product unsafe and it should not be used. Shipping damaged product should be returned promptly. Subsequently damaged product packaging requires product replacement. Product used in the operating room must be opened and placed into use using accepted operating room sterile technique.
The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cycle is saturated steam at 270° F for 30 minutes.
3
10. Equivalence:
Based on the materials, intended uses, design and clinical performance and surgical technique, the Æqualis® Shoulder Prosthesis is substantially equivalent to the above referenced legally marketed devices.
11. Feature Comparison Table:
| FEATURE | Æqualis Press Fit | Æqualis Cement | Biomodular | Neer II | SE? |
|---|---|---|---|---|---|
| Indications for Use(s): | Hemi and total | ||||
| shoulder replacment | Same | Same | Same | Yes | |
| Materials: | |||||
| Stem | |||||
| Humeral Heads | |||||
| Glenoid | Ti6Al4V | ||||
| CoCr | |||||
| UHMWPE | Same | Ti, 6AI,4V, Ti, CrCo | CrCo | Yes | |
| Sizes: | |||||
| Stem | |||||
| Humeral Head | |||||
| Glenoid | 7-15mm | ||||
| 12 sizes | |||||
| 3 sizes | Same | 6-13mm diameter | |||
| in 1mm increments | 6.3-12.7mm in | ||||
| 2mm | |||||
| increments | Yes | ||||
| Standards | |||||
| Specifications: | |||||
| Titanium | |||||
| Cobalt-chromium | |||||
| UHMWPE | ISO 5832-3 | ||||
| ISO 5832-4 | |||||
| ISO 5834-2 | ISO 5832-3 | ||||
| ISO 5832-4 | |||||
| ISO 5834-2 | ASTM F136 | ||||
| ASTM F90-87 | |||||
| ASTM F648 | Yes | ||||
| Method of Fixation: | Uncemented or | ||||
| Cemented | Cemented | Uncemented or | |||
| Cemented | Uncemented or | ||||
| Cemented | Yes | ||||
| Manufacturer: | Tornier, S.A. | Tornier, S.A. | BioMet | Zimmer, 3M | Yes |
| K - Number | K980244 | 952928 | K872454 | K790987 | Yes |
4
Image /page/4/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 a bird-like figure.
ﮩﺮ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 23 1999
Mr. David W. Schlerf Representing Tornier S.A. Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, California 94520
Re : K980244 Aequalis Press Fit Shoulder Prosthesis Regulatory Class: III Product Codes: KWS and HSD Dated: April 5, 1997 Received: April 13, 1997
Dear Mr. Schlerf:
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 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). This decision is based on the glenoid component of this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- The glenoid component of this device may not be labeled 1. or promoted for non-cemented use.
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the glenoid component is intended for cemented use only.
- Any non-cemented fixation of the glenoid component is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
5
Page 2 - Mr. David W. Schlerf
ﯩ
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
6
Page 3 - Mr. David W. Schlerf
obtained from the Division of Small Manufacturers Assistance
Carol Caronal (1984) can 2011 or (301) 443-6597 or 2 obtained from the Division of Small Manuracyard (201) 443-65597 or at
at its toll-free number (800) 638-2041 cc (400) " at its toll-tree number (800) 638-2041 of (302) 183-2007 100 (100 mm)
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Æqualis® Shoulder Prosthesis January 15, 1998
Page 1 ________of ____________________________________________________________________________________________________________________________________________________________ 1
Equalis® Shoulder Prosthesis Device Name:
Indications For Use:
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and other disorders in which arthrodesis is not an acceptable option.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980244 |
|---|---|
| --------------- | --------- |
| Prescription Use | + | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional format 1-2-96) |
Press Fit.doc
.. '