(219 days)
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an orthopedic implant designed to replace parts of the humerus and associated joints, explicitly indicated for treating various medical conditions and injuries.
No
Explanation: The device is an orthopedic implant for joint replacement, revision, and fracture treatment, not for diagnosing conditions.
No
The device description clearly states it is a "multi-piece orthopedic implant designed to replace the humerus," indicating it is a physical hardware device, not software only.
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 Comprehensive Segmental Revision System is described as a "multi-piece orthopedic implant designed to replace the humerus." This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended uses listed are all related to surgical procedures and the replacement of bone and joints due to various conditions (degenerative joint disease, revision, deformity, oncology, fractures). None of the intended uses involve analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, or the generation of diagnostic results from biological specimens.
Therefore, the Comprehensive Segmental Revision System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Comprehensive® Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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. For the US and Canada only: reverse application is limited to proximal humeral replacement.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS, MBF, JDC
Device Description
The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, shoulder, elbow
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/Justification:
- Coating Characterization
- Fatigue Strength Report Flanges
- Fatigue Strength Analysis Humeral Stems
- Shot Peen Testing Summary
- MRI
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.
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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 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 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.
July 12, 2023
Biomet Orthopedics Alexandria Irwin Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K223631
Trade/Device Name: Comprehensive Segmental Revision System(SRS) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, MBF, JDC Dated: June 15, 2023 Received: June 16, 2023
Dear Alexandria Irwin:
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
1
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 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,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2023.07.12
Farzana Sharmin, Ph.D. 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)
Device Name
Comprehensive Segmental Revision System(SRS)
Indications for Use (Describe)
The Comprehensive® Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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. For the US and Canada only: reverse application is limited to proximal humeral replacement.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a clean and professional look.
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 Segmental Revision System (SRS) 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, "Format for Traditional and Abbreviated 510(k)s", issued September 13, 2019.
| Sponsor: | Biomet Orthopedics
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------|
| Contact Person: | Alexandria Irwin
Regulatory Affairs Specialist
Telephone: (1-574-373-0167) | | |
| Date: | July 11, 2023 | | |
| Subject Device: | Trade Name: Comprehensive Segmental Revision System (SRS)
Common Name: Shoulder/Elbow Replacement Prosthesis | | |
| | Classification Name:
PHX- Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) KWT - Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650) KWS - Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660) MBF - Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3670) JDC - Elbow joint metal/polymer constrained cemented prosthesis (21 CFR 888.3150) | | |
| Predicate Device(s): | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp |
| Reference Devices: | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet Inc |
| | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive
Standard Baseplate, Comprehensive
Mini Baseplate | Biomet Manufacturing Corp |
5
Image /page/5/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a contrast against the white background.
Comprehensive Nano Stemless K182516 Shoulder
Biomet Manufacturing Corp
Purpose and Device
The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.
The components of the Comprehensive SRS system(including the Modular Porous Plasma (PPS) Augments) have previously been cleared for use in hemi and anatomic total shoulder replacement in K111746. K173411 expanded the indications for the Comprehensive Segmental Revision System(SRS) to include revere shoulder applications, however at the time the PPS Augments were not being marketed, therefore they were not included in the submission.
The purpose of this submission is:
- To expand the indications to include reverse shoulder applications for . the PPS Augments. The PPS Augments have been previously cleared in K111746.
- To document changes since original clearance for the PPS Augments ●
- To document changes since K173411 for the rest of the ● Comprehensive Segmental Revision (SRS)System
Intended Use and Indications for Use:
The Comprehensive Segmental Revision System is intended for use in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
6
Image /page/6/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside it, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color. The logo is simple and modern.
| Biomet Comprehensive Segmental Revision System is indicated for use in a
reverse application 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. For the US and Canada only:
| Reverse application is limited to proximal humeral replacement. | |
|---|---|
| The Comprehensive Segmental Revision System is intended for use with | |
| or without bone cement in the proximal shoulder. | |
| The Comprehensive Segmental Revision System is intended for use with | |
| bone cement in distal humeral and total humeral applications. | |
| Tissue Attachment Augments provide the option for tissue stabilization | |
| and attachment. Tissue Attachment Augments are not available in all | |
| markets. | |
| Summary of Technological | |
| Characteristics: | The rationale for substantial equivalence is based on consideration of the |
| following characteristics: | |
| • Intended Use: Identical to predicates | |
| • Indications for Use: Similar to predicates | |
| • Materials: Similar or identical to predicates | |
| • Design Features: Similar or identical to predicates | |
| • Sterilization: Identical to predicates | |
| Summary of Performance Data | |
| (Nonclinical and/or Clinical) | • Non-Clinical Tests/Justification: |
| ○ Coating Characterization | |
| ○ Fatigue Strength Report Flanges | |
| ○ Fatigue Strength Analysis Humeral Stems | |
| ○ Shot Peen Testing Summary | |
| ○ MRI | |
| • Clinical Tests: | |
| ○ None provided | |
| Substantial Equivalence | |
| Conclusion | The proposed expansion of indication for the PPS Augments in the |
| Comprehensive SRS will give the PPS Augments the same intended use | |
| and indications for use as the rest of the Comprehensive SRS System. The |
proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:
- any differences do not raise different questions of safety and • effectiveness; and
- the proposed device is at least as safe and effective as the legally . marketed predicate devices