(132 days)
No
The 510(k) summary describes a mechanical implant system for shoulder arthroplasty. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical fatigue and range of motion, not algorithmic performance.
Yes
The device is a total shoulder replacement system intended to relieve pain and significant disability, which directly aligns with the definition of a therapeutic device.
No
This device is a shoulder replacement system (arthroplasty) intended for therapeutic purposes (replacing damaged joint surfaces), not for diagnosing medical conditions.
No
The device description clearly indicates it is a total shoulder replacement system, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for shoulder joint arthroplasty, which is a surgical procedure to replace a damaged joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a total shoulder replacement system, replacing damaged articular surfaces. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The device itself is the treatment.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended for shoulder joint arthroplasty.
(IFU 01-50-0903 Biomet® Comprehensive® Reverse Shoulder Products)
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.
(IFU 01-50-0890 Biomet® Comprehensive® Reverse Shoulder Screws)
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.
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:
- Fatigue Strength Testing was completed to demonstrate that the modifications do not adversely impact the fatigue strength of the Comprehensive trays and humeral constructs under a clinically motivated unconstrained fixture conditions. The test method noted in the previous testing submitted with K113069, Comprehensive Reverse Humeral Tray Medium Fatigue Strength Determination, and the test report presented in this submission are sufficiently different such that the test results cannot be directly compared. Fatigue testing was performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN) to demonstrate that the Humeral bearing and tray construct could withstand a fatigue load of 566N for 5 million cycles. Zimmer Biomet established a laboratory fatigue test method and requirement for shoulder implant system based on extensive literature review as described in the test report.
- Range of Motion analysis provides verification of the Range of Motion (ROM) conformance to ASTM F1378-12.
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.
K080642, K113069, K113121, K120121, K131353, K132239, K152754
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.
Not Found
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
April 15, 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 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.
Biomet Inc. Kari Hovorka Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 WARSAW, IN 46581
Re: K193373
Trade/Device Name: Comprehensive® Reverse Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: March 17, 2020 Received: March 18, 2020
Dear Kari Hovorka:
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 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) K193373
Device Name Comprehensive® Reverse Shoulder
Indications for Use (Describe) (IFU 01-50-0903 Biomet® Comprehensive® Reverse Shoulder Products)
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 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.
(IFU 01-50-0890 Biomet® Comprehensive® Reverse Shoulder Screws)
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 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.
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
3
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4
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 Reverse Shoulder 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 September 13, 2019.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Kari Hovorka
Regulatory Affairs Specialist
Telephone: (877.652.0830) |
| Secondary Contact Person: | Jared Cooper
Regulatory Affairs Manager
Telephone: (574-372-1941) |
| Date: | December 2, 2019 |
| Subject Device: | Trade Name: Comprehensive® Reverse Shoulder
Common Name: Shoulder Prosthesis,
Reverse Configuration
Classification Name:
Shoulder joint metal/polymer semi-constrained cemented prosthesis
PHX – Shoulder Prosthesis, Reverse Configuration (21 CFR 888.3660) KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (21 CFR 888.3660) |
Predicate Device(s):
| Predicates | 510(k) Number |
|---|---|
| Comprehensive Reverse Shoulder | K080642 - |
| Primary | |
| Comprehensive Reverse Shoulder – Humeral Trays | K113069 |
| Comprehensive Reverse Shoulder – E1 (Poly) Humeral Bearings | K113121 |
| Comprehensive Reverse Shoulder – Mini Baseplate | K120121 |
| Comprehensive Reverse Shoulder – Titanium Glenospheres | K131353 |
5
| Comprehensive Reverse Shoulder – Screws | K132239 |
|---|---|
| Comprehensive Vault Reconstruction System (VRS) | K152754 |
| Purpose and Device
Description: | The purpose of this submission is:
To provide a cumulative assessment of design changes made
to the system since original clearance; The subject Glenosphere devices introduce a modified
inner surface finish and a pilot hole modification; The subject Humeral Tray and the Humeral Bearing
devices introduced dimensional modifications; To document previously cleared (K152754) compatibility
between the Comprehensive® Reverse Shoulder and the
Trabecular Metal™ Reverse Shoulder; To update labeling in order to bring the Instructions for Use
up to current practices; To insure that the all of the instrumentation/accessories for
use with this system are appropriately associated with a
510(k). |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Description:
The Comprehensive® Reverse Shoulder (CRS) is a total shoulder
replacement system in a reverse configuration. The CRS was
designed to provide a complete, seamless system based on the
Comprehensive Shoulder platform by avoiding the need to
remove a well-fixed humeral stem associated with a prior
anatomical shoulder arthroplasty for conversion to reverse
shoulder arthroplasty. This is made possible because the CRS can
utilize any of the existing Comprehensive stems, including
primary, revision, or fracture stems in cemented or uncemented
applications. The CRS performs its function by replacing the
damaged or diseased articular surfaces of the native shoulder with
artificial surfaces with the intent to improve shoulder function
and/or reduce shoulder pain. |
| Intended Use and
Indications for Use: | These devices are intended for shoulder joint arthroplasty.
(IFU 01-50-0903 Biomet® Comprehensive® Reverse Shoulder
Products)
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. |
6
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.
(IFU 01-50-0890 Biomet® Comprehensive® Reverse Shoulder Screws)
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.
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.
7
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.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate ●
- . Indications for Use: Similar to predicate: the subject devices have similar indications as compared to the predicate devices. The modifications to the indications does not alter the safety or efficacy of the subject devices. The change is not a result of safety or performance issues nor is the intent to significantly improve safety to efficacy. No new risks result from the change in indications wording.
- Materials: Identical to predicate.
- Design Features: Similar to predicate; the design changes . made to the subject Comprehensive Reverse Shoulder device include addition of a 30-grit blast finish process to the inner surface of the glenosphere components, diameter reduction of the pilot hole of glenosphere components, refinement of tolerance band of the fillet between the taper and base of the tray, and narrowing of the interior notch width of the humeral bearings.
- Sterilization: Similar to predicate; ArComXL Humeral Bearings devices were cleared to be sterilized with either EtO or Gas Plasma sterilization in K080642. Subject ArComXL Humeral Bearings devices are provided sterile by Gas Plasma, with no changes to the sterilization parameters as cleared in K080642. The remaining subject components have identical sterilization parameters to predicate devices.
Summary of Performance Data: (Nonclinical and/or Clinical)
Non-Clinical Tests:
- Fatigue Strength Testing was completed to demonstrate ● that the modifications do not adversely impact the fatigue strength of the Comprehensive trays and humeral constructs under a clinically motivated unconstrained fixture conditions. The test method noted in the previous testing submitted with K113069, Comprehensive Reverse Humeral Tray Medium Fatigue Strength Determination, and the test report presented in this submission are sufficiently different such that the test results cannot be directly compared. Fatigue testing was performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN) to demonstrate that the Humeral bearing
Summary of Technological Characteristics:
8
and tray construct could withstand a fatigue load of 566N for 5 million cycles. Zimmer Biomet established a laboratory fatigue test method and requirement for shoulder implant
system based on extensive literature review as described in the test report.
- . Range of Motion analysis provides verification of the Range of Motion (ROM) conformance to ASTM F1378-12.
Clinical Tests:
- None provided .
Substantial Equivalence Conclusion:
The subject Comprehensive Reverse Shoulder has the same intended use and similar indications for use as the subject devices. The subject devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that:
- any differences do not raise new questions of safety and effectiveness; and
- the subject devices are at least as safe and effective as the legally marketed predicate devices.