(138 days)
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.
The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.
This document is a 510(k) Summary for the Zimmer Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, and Comprehensive Mini Baseplate. It describes the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of a medical device submission for substantial equivalence to predicates, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.
The acceptance criteria and device performance are described in terms of engineering and material characteristics for orthopedic implants.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the non-clinical tests performed to demonstrate substantial equivalence. These are not performance metrics in the sense of accuracy, sensitivity, or specificity as would be the case for AI/ML models, but rather engineering and material properties.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (Summary) |
|---|---|
| PPS and HA/TCP Coating Pore Size and Porosity | Not explicitly detailed, but implied to be compliant with acceptance criteria as part of the overall "Substantial Equivalence Conclusion" |
| Glenoid Loosening/Disassociation Test Method | Not explicitly detailed, but implied to be compliant. |
| Shear Testing Justification | Justified |
2. Sample Size Used for the Test Set and the Data Provenance
This is an orthopedic implant 510(k) submission, not a study of an AI/ML device. Therefore, the concept of a "test set" in the machine learning sense, or data provenance in terms of patient data origin and retrospectivity/prospectivity, is not applicable. The documentation refers to mechanical and material testing, which would have specific sample sizes for engineering tests (e.g., number of specimens tested for shear strength, porosity), but these details are not provided in this summary document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML device that requires human expert review for establishing ground truth on image data or similar. The "ground truth" here refers to established engineering standards and material specifications.
4. Adjudication Method for the Test Set
Not applicable. Ground truth establishment for AI/ML model test sets.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
Not applicable. This is not an AI/ML device where human readers interact with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to:
- Engineering Standards and Material Specifications: The device's performance against established industry standards for orthopedic implants, including mechanical strength, durability, material composition (e.g., PPS and HA/TCP coating properties), and resistance to loosening/disassociation.
- Predicate Device Performance: The comparison of the proposed device's characteristics to those of legally marketed predicate devices, demonstrating that any differences "do not raise new questions of safety and effectiveness."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Device and Performance Aspects from the Document:
- Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
- Purpose: Manufacturing of alternate versions of existing Comprehensive Standard and Mini Baseplates with a different porous plasma spray (PPS) coating vendor and the addition of Zimmer's Calcicoat coating. Also includes a new Comprehensive Reverse Augmented Baseplate with an augmented backside.
- Basis for Substantial Equivalence:
- Intended Use & Indications for Use: Identical to predicate devices.
- Materials: Substrate and porous coating are the same as the predicate; Calcicoat® coating has been previously cleared.
- Design Features: Identical or similar to predicates.
- Sterilization: Identical assurance level and validation methods to predicate (new vendor).
- Performance Data Provided: Non-clinical tests were conducted. These included assessments of PPS and HA/TCP Coating Pore Size and Porosity, Glenoid Loosening/Disassociation Test Method, and Shear testing justification. No clinical tests were provided.
- Conclusion: The proposed devices are deemed substantially equivalent because they have the same intended use and indications for use, similar technological characteristics, and the differences do not raise new questions of safety and effectiveness, meaning they are at least as safe and effective as the legally marketed predicate devices.
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January 3, 2018
Biomet Manufacturing Corp Patricia Sandborn Beres Regulatory Affairs Specialist 56 E. Bell Drive Warsaw, Indiana 46582
Re: K172502
Trade/Device Name: Comprehensive Augments, Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, PAO, KWS, KWS, KWT, MBF Dated: December 1, 2017 Received: December 4, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K172502 |
| Device Name | Comprehensive Reverse Shoulder Standard and Mini BaseplatesComprehensive Augmented Glenoid Baseplates |
| Indications for Use (Describe) | Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. |
| The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. | |
| Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. | |
| Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. | |
| Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. | |
| 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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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the words "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color. The logo is clean and modern, and it is likely used to represent the company's brand.
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 Comprehensive Glenoid Components 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: | Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1835034 |
|---|---|
| Contact Person: | Patricia Sandborn BeresRegulatory Affairs PrincipalTelephone: (574-267-6639)Fax: fax (574-371-1683) |
| Date: | January 3, 2018 |
| Subject Device: | Trade Name: Comprehensive Augmented Glenoid Components,Comprehensive Standard Baseplate, Comprehensive Mini BaseplateCommon Name: Shoulder Replacement ProsthesisClassification Name:• PHX- Shoulder Prosthesis, Reverse Configuration (21CFR888.3660)• PAO- prosthesis, shoulder, semi-constrained, metal/polymer +additive, cemented (21 CFR 888.3660)• KWS - prosthesis, shoulder, semi-constrained, metal/polymercemented (21 CFR 888.3660)• KWT - prosthesis, shoulder, non-constrained, metal/polymercemented (21 CFR 888.3650)• MBF - prosthesis, shoulder, semi-constrained, metal/polymer,uncemented (21 CFR 888.3670) |
Predicate Device(s):
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Comprehensive Reverse Shoulder – MiniBaseplate | Biomet, Inc. | K120121 |
| Comprehensive Reverse Shoulder | Biomet, Inc. | K080642 |
| Equinoxe Reverse Total Shoulder System | Exactech, Inc. | K110708 |
| Comprehensive Reverse Shoulder – TitaniumGlenosphere | Biomet, Inc | K131353 |
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| Purpose and Device Description: | This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates\ components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating. |
|---|---|
| Intended Use and Indications for Use: | Reverse Applications:The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. |
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Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate ●
- Indications for Use: Identical to predicate
- Materials: Substrate and porous coating is the same as the . predicate; Calcicoat® coating has been previously cleared for orthopedic products
- Design Features: Identical or similar to predicates .
- Sterilization: Identical assurance level and validation methods to ● predicate (new vendor)
Summary of Performance Data:
| Non-Clinical Tests: PPS and HA/TCP Coating Pore Size and Porosity Glenoid Loosening/Disassociation Test Method Shear testing justification Clinical Tests: None provided |
|---|
| Substantial Equivalence Conclusion: The proposed Comprehensive Glenoid Baseplates have the same intended use and indications for use as the predicate devices. The proposed devices have 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 devices are at least as safe and effective as the legally marketed predicate devices.
§ 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.”