(110 days)
No
The summary describes a mechanical implant (glenoid components for shoulder replacement) and its intended use and testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical properties and material characteristics.
Yes
The device is an implantable component for total shoulder replacement used to treat medical conditions like osteoarthritis, rheumatoid arthritis, and fractures, aiming to correct functional deformities and alleviate difficult clinical management problems. These are clear therapeutic interventions.
No
Explanation: This device is a glenoid component, which is an implant used in total shoulder replacement surgery for treatment of joint diseases and fractures, not for diagnosing them.
No
The device description clearly outlines physical components made of materials like polyethylene and Tivanium, intended for surgical implantation. The performance studies also focus on the mechanical properties and wear of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for the surgical treatment of various conditions affecting the shoulder joint (osteoarthritis, rheumatoid arthritis, fractures, etc.). These are clinical indications for a surgical implant, not for testing samples from the human body to diagnose or monitor a condition.
- Device Description: The device is described as a series of glenoid components (part of a shoulder replacement). This is a physical implant intended for surgical insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing.
- Performance Studies: The performance studies listed are related to the mechanical properties and performance of the implant itself (corrosion, fatigue, loosening, wear, range of motion), not to the accuracy or reliability of diagnostic results.
In summary, the Alliance Glenoid is a surgical implant designed to replace a portion of the shoulder joint, not a device used for in vitro diagnostic testing.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT
Device Description
The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central 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
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)
Non-Clinical Tests:
- Accelerated Corrosion (ASTM F2028)
- Fatigue of Modular Connection (ASTM F2028)
- Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Range of Motion (ROM) (ASTM F1378)
- Wear Analysis (ASTM F1378)
- Porous Structure Characterization - TM (ASTM 1854)
- Porous Structure Characterization PPS (ASTM 1854, ASTM F1160, ASTM F1044, ASTM F1147, ASTM F1978)
- MR Evaluation (ASTM F2119, ASTM F2052, ASTM F2182)
Clinical Tests:
- None provided
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.
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.
K040432, K172502, K071090, K030710
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
October 23, 2019
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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Zimmer Inc. Patricia Sandborn Beres Regulatory Affairs Principal P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K191814
Trade/Device Name: Alliance 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: September 20, 2019 Received: September 23, 2019
Dear Patricia Sandborn 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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) K191814
Device Name Alliance 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.
-
- Difficuit 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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 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: | October 21, 2019 |
| Subject Device: | Trade Name: Alliance 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 | Modular Hybrid Glenoid | Biomet | K060694 |
| Secondary Predicate | Bio-Modular Shoulder
System - Pegged Glenoid | Biomet | K030710 |
| Reference Predicates | | | |
| Reference Predicate for
2-Pegged Glenoid | Solar 2 Anatomic Shoulder | Stryker | K040432 |
| Reference Predicate for
PPS Coating | Comprehensive
Augmented Glenoid | Biomet | K172502 |
| Reference Predicate for
TM material | Trabecular Metal Glenoid | Zimmer | K071090 |
| Reference Predicate for
testing | Bigliani/Flatow Glenoid | Zimmer | K030710 |
4
Purpose and Device Description:
The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central 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.
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Fractures of the proximal humerus, where other 4. 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.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical 0
- 0 Indications for Use: Similar - surgeon may opt to use the primary implants in a revision surgery
- 0 Materials: All materials have previously been used for shoulder glenoid replacement components
Intended Use and Indications for Use:
Summary of Technological Characteristics:
5
- Design Features: Similar to predicates ●
- . Sterilization: Identical to predicate
Summarv of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: .
- O Accelerated Corrosion (ASTM F2028)
- Fatigue of Modular Connection (ASTM F2028) O
- o Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Range of Motion (ROM) (ASTM F1378) O
- Wear Analysis (ASTM F1378) o
- o Porous Structure Characterization - TM (ASTM 1854)
- Porous Structure Characterization PPS (ASTM o 1854, ASTM F1160, ASTM F1044, ASTM F1147, ASTM F1978)
- MR Evaluation (ASTM F2119, ASTM F2052, o ASTM F2182)
- Clinical Tests: ●
- None provided o
Substantial Equivalence Conclusion
The proposed Alliance 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