(177 days)
No
The device description focuses on the physical characteristics and materials of a shoulder implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is a prosthetic replacement indicated to relieve severe pain or significant disability, which aligns with the definition of a therapeutic device.
No
The device description indicates it is a prosthetic replacement component for total shoulder arthroplasty, which is a treatment, not a diagnostic tool.
No
The device description clearly states it is a physical implant made of UHMWPE with a Cobalt-Chromium wire, intended for surgical implantation. It 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 clearly describes a surgical implant for prosthetic replacement of the gleno-humeral 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 details a physical implant made of UHMWPE and Cobalt-Chromium, designed to be surgically implanted into the shoulder joint.
- 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 compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
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 gleno-humeral joint; non-union humeral head fracture; displaced 3 and 4 proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
Product codes
87KWS
Device Description
The Aequalis Universal Shoulder Glenoid is intended for cemented use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the Tornier Aequalis Total Shoulder System. The Aequalis Universal Shoulder Glenoid is manufactured in four sizes from Ultra High Molecular Weight Polyethylene (UHMWPE). The component's articulating (or lateral) surface is concave and is designed to articulate with the head of an existing, commercially available Tornier Aequalis Shoulder humeral prosthesis. The Aequalis Universal Shoulder Glenoid aticulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and the humeral head is intended to allow the translation of the head in the superior/inferior and anterior/posterior directions.
The back surface of the Aequalis Universal Shoulder Glenoid is spherical in geometry, in order to conform to the geometry of the glenoid fossa. It is grooved in order to increase the interface glenoid implant / bone cement.
The back (or medial) surface of the component has either a keel or four pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in four sizes (small, medium, large and X-large) for each component, the keeled and pegged components.
- The Aequalis Universal pegged Glenoid features one centrally located peg and three t peripheral pegs placed in a triangular configuration. The peripheral pegs are fitted with transversal grooves that provide enhanced cement fixation. The three peripheral pegs provide resistance to rocking and rotational motion caused by translation of the prosthetic humeral head. The central peg features an X-ray marking wire in Cobalt-Chromium alloy.
- -The Aequalis Universal keeled Glenoid features a centrally located keel to provide translational and rotational stability of the implant. A groove around the middle of the keel provides enhanced cement fixation. The keel features an X-ray marking wire in Cobalt-Chromium alloy.
Materials. The Aequalis Universal Shoulder Glenoid is manufactured from implant grade ultrahigh molecular weight polyethylene (UHMWPE) according to ISO5834-2, with a small Cobalt-Chromium wire included as an opaque radiographic marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, gleno-humeral joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Only surgeons fully experienced in total arthroplasty surgical technique of the shoulder should utilize the device.
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)
Selected device testing demonstrates the functional equivalence of the Aequalis Universal Shoulder Glenoid. A feature comparison table is used to graphically present important parameters of the available systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K990136, K981487, K962082, K962238, K962244, K960906
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
510(k) SUMMARY of Safety and Effectiveness Information
In accordance with the Food and Drug Administration Rule to implement provisions of the safe Medical devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Aequalis Universal Shoulder Glenoid.
| Manufacturer: | TORNIER, S.A.
Rue du Doyen Gosse
38330 SAINT-ISMIER / France
Registration No : 9610667 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| US Representative: | Mr. David W. SCHLERF
BUCKMAN Company, Inc.
200 Gregory Lane, Suite C-100
Pleasant Hill, CA 94523-3389 |
| Date: | September 23, 1999 |
| Contact Person: | Anne LE ROUZO
Regulatory Affairs & Quality Manager |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented
prosthesis - 21CFR888.3660 |
1. Classification:
$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 Titanium or 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 $888.3.
The Orthopedic and Rehabilitation Devices Panel assigned the unique device classification Product Code 87KWS to this device.
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16954393
2. Voluntary standard:
Various voluntary performance standards are utilized. They include Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures, Quality System Regulations (QSR), ISO9001 & EN46001 specifications, and European CE Marking.
3. Labeling / Packaging:
Labeling complies with all FDA requirements in effect at the time of device review and clearance. Warning and caution statements are displayed as appropriate. Professional information is available from Tornier and is supplied with all product ordered. Please obtain and review all product information before using the system. Only the information supplied with the product is to be considered current and complete.
The Aequalis Universal Shoulder Glenoid offers all components in double blister-type peel packs. This is an industry typical package obtained from commercial suppliers of such packaging.
4. Device Description:
Description. The Aequalis Universal Shoulder Glenoid is intended for cemented use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the Tornier Aequalis Total Shoulder System. The Aequalis Universal Shoulder Glenoid is manufactured in four sizes from Ultra High Molecular Weight Polyethylene (UHMWPE). The component's articulating (or lateral) surface is concave and is designed to articulate with the head of an existing, commercially available Tornier Aequalis Shoulder humeral prosthesis. The Aequalis Universal Shoulder Glenoid aticulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and the humeral head is intended to allow the translation of the head in the superior/inferior and anterior/posterior directions.
The back surface of the Aequalis Universal Shoulder Glenoid is spherical in geometry, in order to conform to the geometry of the glenoid fossa. It is grooved in order to increase the interface glenoid implant / bone cement.
The back (or medial) surface of the component has either a keel or four pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in four sizes (small, medium, large and X-large) for each component, the keeled and pegged components.
- The Aequalis Universal pegged Glenoid features one centrally located peg and three t peripheral pegs placed in a triangular configuration. The peripheral pegs are fitted with transversal grooves that provide enhanced cement fixation. The three peripheral pegs provide resistance to rocking and rotational motion caused by translation of the prosthetic humeral head. The central peg features an X-ray marking wire in Cobalt-Chromium alloy.
- -The Aequalis Universal keeled Glenoid features a centrally located keel to provide translational and rotational stability of the implant. A groove around the middle of the keel provides enhanced cement fixation. The keel features an X-ray marking wire in Cobalt-Chromium alloy.
Materials. The Aequalis Universal Shoulder Glenoid is manufactured from implant grade ultrahigh molecular weight polyethylene (UHMWPE) according to ISO5834-2, with a small Cobalt-Chromium wire included as an opaque radiographic marker.
Indications. The Aequalis Universal Shoulder Glenoid, in conjunction with their corresponding humeral component, are intended for total shoulder arthroplasty. The indications for use are as follows:
2
R99 435 3
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the gleno-humeral joint; non-union humeral head fracture; displaced 3 and 4 proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
Contraindications and Cautions. Only surgeons fully experienced in total arthroplasty surgical technique of the shoulder should utilize the device. Please contact Tornier about available instructional course demonstrations and bio-skills workshops.
5. Packaging and Sterilization Information:
The prostheses are supplied sterile from Tornier. The technique used to achieve the sterilization is known as gamma radiation sterilization. A radiation dose of at least 2.5 Mrad is utilized. The sterility assurance level (SAL) is 10 . The validation of the sterilization has been carried out according to the standard EN552.
The implant is contained in a double sealed blister pack in order to maintain sterility. Once the packaging is opened, the implant must never be resterilized. In case of packaging is damaged, the implant must be rejected.
The instruments required to properly use the device are provided non-sterile. They must be decontaminated, cleaned and sterilized prior to each surgery. All packaging, labeling and shipping materials must be removed from the instruments prior any operation. The recommended sterilization method is steam sterilization at 274°F for 18 minutes.
6. Summary of Safety and Effectiveness Information.
This summary contains information upon which a determination of substantial equivalence could be based. Selected device testing demonstrates the functional equivalence of the Aequalis Universal Shoulder Glenoid. A feature comparison table is used to graphically present important parameters of the available systems. The comparison table is identified as Table 1, located after the Class III Summary section.
7. Class III Certification
Tornier, S.A. certifies that a reasonable search of all information known or otherwise available to Tornier, S.A. about the types and causes of reported safety and/or effectiveness problems for total shoulder prostheses has been conducted. Tornier, S.A. further certifies that the types of problems to which the Aequalis Universal Shoulder Glenoid is susceptible and their potential causes are listed in the following Class III summary, and that this Class III summary is complete and accurate.
8. Class III Summary
The most frequently reported problems associated with shoulder glenoid implant fall into two basic groupings, procedure related and device related.
Of the procedure related risks, infection, vascular injury, nerve injury and bony trauma are most often reported. Since the Aequalis Universal Shoulder Glenoid is intended to be implanted only by qualified orthopedic experts and utilizes the basic surgical technique and fixation methods as the
3
199435 3
other devices, procedure related adverse events can reasonably be expected to be equivalent in occurrence.
Of the reviewed device related events, disassociation of one or more of the system components are the most frequently cited complications. A few isolated intra-articular wear debris and device loosening reports were also noted as case reports in the literature.
Glenoid component failures typically occur in devices made of a metal tray and a polyethylene insert. The polyethylene insert may be sheared away or unsnapped from the cemented metallic base. Since the Aequalis Universal Shoulder Glenoid component made component made completely from polyethylene, this particular type of failure cannot occur. Disassociation of polyethylene glenoid components does occur and is mostly related to failure of the cement mantle and/or an extraordinary post-surgical traumatic event. The Aequalis Universal Shoulder Glenoid will be subject to such glenoid failure. Cement interface failure and traumatic glenoid failure mav be expected to occur in much the same way and frequency as other shoulder systems.
Device loosening is primarily related to cement/implant failure. The frequency of this occurrence on the glenoid is related to site preparation, technique and handling of the bone cement. It is not expected that the occurrence of this particular adverse event will be any higher or lower when using the Aequalis Universal Shoulder Glenoid.
Medical Device Reporting (MDR) experience for the Aequalis Universal Shoulder Glenoid is unknown because United States distribution of the System has not occurred as of this summary.
4
S10(k) Premarket Notification
ABLE 1 / Comparison table:
| Feature or
System
Characteristics | TORNIER
Aequalis Universal
Shoulder Glenoid | TORNIER
Aequalis Shoulder
System | SULZER
Orthopedics
Anatomica
Glenoid
Component | DEPUY
Global
Shoulder
Glenoid | OSTEONICS
All-Polyethylene
Glenoid
Shoulder
Component | INTERMEDICS
Select Shoulder
Keeled All-Poly
Glenoids | INTERMEDICS
Select Shoulder
Pegged All-Poly
Glenoids | ENCORE
Glenoid component
for the Foundation
Total Shoulder
System | SE? |
|-----------------------------------------|---------------------------------------------------|----------------------------------------|------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------|-----|
| Materials | UHMWPE | Same | Same | Same | Same | Same | Same | Same | Yes |
| Method of
Fixation | Cemented | Same | Same | Same | Same | Same | Same | Same | Yes |
| Keel or Pegs
Indications for
Use | Keel / Pegs | Keel | Pegs | Pegs | Keel | Keel | Pegs | Keel / Pegs | Yes |
| Standards
Specifications | Total Shoulder
replacement | Same | Same | Same | Same | Same | Same | Same | Yes |
| UHMWPE | ISO 5834-2 | Same | ASTM F 648 | ASTM F
648 | ASTM F 648 | ASTM F 648 | ASTM F 648 | ASTM F 648 | Yes |
| K-number | PENDING | K952928 &
K980244 | K990136 | K981487 | K962082 | K962238 | K962244 | K960906 | |
equalis Universal Shoulder Glenoid
化与9435 3
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The figure is composed of three curved lines that form the shape of a person's head and torso. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Public Health Service
JUN 2 2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David W. Schlerf Representing Tornier, S.A. Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389
Re: K994393
Trade Name: Æqualis® Universal Shoulder Glenoid Regulatory Class: III Product Code: KWS Dated: November 21, 1999 Received: December 28, 1999
Dear Mr.Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notificantially equivalent (for the indications for use above and we nave delerinned the devices is babbarated in the May 28, 1976, the stated in the enclosure) to device marketed in more and have been reclassified in
enactment date of the Medical Device American Frances Coamsia Act (Act) . You may enactment date of the Medical Device Amendison, Orug, and Cosmetic Act (Act). You may,
accordance with the provisions of the Federal Food, Drug, and Cosmetic Act. The genera accordance with the provisions of the rederal control provisions of the Act. The general therefore, market the device, subject to the general registration, listing of devices, control provisions of the Act include requirements received on the mastranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into cities in controls. Existing major regulations.
(Premarket Approval), it may be subject to such additions Title 21 Parts 800 (Premarket Approval), it may of subject to such additions, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, wroppt Cood allecting your device can or round in the assumes compliance with the current Good
A substantially equivalent determination assumes compliance with the coulding ( A substantially equivalent decemination as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requirement, as secrets at 820 and that, through periodic (QS)
Medical Devices: General regulation (21 CFR Parts and that, the searchings - 59 Medical Devices: General regulation (21 °CF ic Part of observer. Frank assumptions. Failure to inspections, the Food and Drug Administration (1) 11-7 action. In addition, FDA may publish comply with the GMF regulation may result in the Federal Register. Please note: this further announcements concerning your device in the reason affect any obligation you might have
response to your premarket notification submission the filestrania Product Red response to your premarket notheation suchnistion as a more the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
6
Page 2 – Mr. David W. Schlerf
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 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/dsmamain.html".
Sincerely yours,
Russell Veysey
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page _ 1 __ of __ 1 __________________________________________________________________________________________________________________________________________________________
K994393 510(k) Number
Æqualis® Universal Shoulder Glenoid Device Name:
Indications For Use:
Prosthetic replacement with this device may be indicated to relieve severe pain Prosinent replacement with this dovice may so oid, or traumatic disease of the or sighting and disablility in dogenoration humeral head fracture; displaced 3 and 4 part glenonumeral joint, non anion namon nead of the humeral head; of proximal numeral fractures, avabana nooroloo anthrodesis or resectional arthroplasty are not acceptable.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Demetri Krys
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ..
Prescription Use
(Per 21 CFR 801.109)
OR