(98 days)
No
The summary describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is indicated for the treatment of non-inflammatory degenerative joint disease (osteoarthritis), rheumatoid arthritis, correction of functional deformity, and fractures, which are conditions that benefit from therapeutic intervention.
No
This device is a glenoid component for total shoulder replacement, intended for treatment of joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly describes physical glenoid components made of materials like Tivanium® and Trabecular Metal, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "series of glenoid components" intended to be used as part of a "total shoulder replacement construct." These are implants designed to be surgically placed within the body.
- Intended Use: The intended uses listed are all related to treating conditions of the shoulder joint through surgical intervention (e.g., osteoarthritis, rheumatoid arthritis, fractures, correction of deformity). These are clinical indications for a surgical implant, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, performing tests on bodily fluids or tissues, or providing diagnostic information.
Therefore, this device is a surgical implant and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Difficult clinical management problems, where other methods of treatment may not be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.
Product codes
KWS, KWT
Device Description
The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.
The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.
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
Prescription Use
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
- Non-Clinical Tests:
- Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Clinical Tests:
- None provided
Key Metrics
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
February 24, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Zimmer Inc. Patricia Beres Regulatory Affairs Principal P.O. Box 708 WARSAW, IN 46581-0708
Re: K193180
Trade/Device Name: Alliance Augmented Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT Dated: January 23, 2020 Received: January 24, 2020
Dear Patricia Beres:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193180
Device Name Alliance Augmented Glenoid
Indications for Use (Describe)
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Difficult clinical management problems, where other methods of treatment may not be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ALLIANCE AUGMENTED GLENOID 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres
Regulatory Affairs Principal
Telephone: (574-267-6639 extension 1278)
Email: patty.beres@zimmerbiomet.com |
| Date: | November 15, 2019 |
| Subject Device: | Trade Name: Alliance Augmented Glenoid
Common Name: Anatomic Glenoid Prosthesis |
| | Classification Name:
• KWS - Prosthesis Shoulder, Semi-Constrained
Metal/Polymer Cemented (21 CFR 888.3660)
• KWT - Prosthesis, Shoulder, Non-Constrained
Metal/Polymer (21 CFR 888.3650) |
Predicate Device(s):
| Predicates | Device | Manufacturer | 510(k)
Number |
|---------------------|-------------------|--------------|------------------|
| Primary Predicate | Alliance Glenoid | Zimmer, Inc. | K191814 |
| Reference Predicate | Aequalis Perform+ | Tornier | K150583 |
Purpose and Device Description:
The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular
4
glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.
The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.
Summary of Technological Characteristics:
The following items are identical between the proposed and predicate devices:
- . Indications for use
- Articulating Geometry
- Sizing (Size 2-5) ●
- . Modular Post attachment
- Polyethylene peripheral peg design and splay
- Material (UHMWPE and Ti-6Al-4V) ●
- Sterilization method (gamma radiation, SAL 10-6) ●
- Instrument Materials
This submission proposed the following design change:
- Addition of a 12.5-degree augment wedge to the ● under surface of the component.
- Addition of associated implant specific instruments ●
Intended Use and Indications for Use:
5
- Updated packaging/sterilization references ●
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests: ●
- o Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Clinical Tests: ● O None provided
Substantial Equivalence Conclusion
The proposed Alliance Augmented Glenoid has the same intended use and indications for use as the predicate device. The proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:
- any differences do not raise new questions of safety and . effectiveness; and
- . the proposed device is at least as safe and effective as the legally marketed predicate device