(72 days)
Not Found
No
The document describes a physical mold used to create a temporary shoulder implant from bone cement. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on the physical properties of the mold and the resulting cement spacer.
Yes
The device is used to mold a temporary hemi-shoulder replacement for patients undergoing a two-stage revision procedure due to a septic process, which directly addresses a medical condition to restore health.
No
The device is a mold used to create a temporary prosthetic (spacer) for revision surgery due to infection; it does not diagnose a condition.
No
The device description explicitly states the device is made of silicone and is a physical mold used to create a temporary prosthesis from bone cement. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The StageOne™ Shoulder Cement Spacer Molds are used to create a physical, temporary implant that is placed inside the patient's body. It is a surgical device used in a two-stage revision procedure.
- Lack of Biological Sample Analysis: The device itself does not analyze any biological samples from the patient. It is a mold used to shape a material (bone cement) that is then implanted.
Therefore, based on the provided information, the StageOne™ Shoulder Cement Spacer Molds fall under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Input:
Biomet, Inc. Neha Sreenath Regulatory Affairs Senior Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581
Re: K221968
Trade/Device Name: StageOne™ Shoulder Cement Spacer Molds Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: July 1, 2022 Received: July 5, 2022
Dear Neha Sreenath:
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 (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 mediation-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.
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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) K221968
Device Name
StageOne™ Shoulder Cement Spacer Molds
Indications for Use (Describe)
Stage One™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
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)
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 Druq 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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 StageOne™ Shoulder Cement Spacer Molds 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, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581, USA
Establishment Registration Number: 1825034 |
|---|---|
| Contact Person: | Neha Sreenath
Regulatory Affairs Senior Specialist
Telephone: (0065-8504 1704) |
| Date: | 01 July 2022 |
| Subject Device: | Trade Name: StageOne™ Shoulder Cement Spacer Molds
Common Name: Temporary Bone Cement Hemi-Shoulder Prosthesis
Classification Name:
• MBB – Polymethylmethacrylate (PMMA) bone cement (21 CFR
888.3027)
• HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented
prosthesis (21 CFR 888.3690)
• KWS - Shoulder joint metal/polymer semi-constrained cemented
prosthesis (21 CFR 888.3660) |
| Predicate Device: | StageOne™ Disposable Cement
Spacer Molds for Temporary Hemi- Biomet, Inc.
K160071
Shoulder Prosthesis |
| Purpose and Device
Description: | The purpose of this submission is to obtain clearance for the proposed
modifications to the manufacturing process, sterile packaging
configuration, product labeling, engineering drawings and indications for
use regarding bone cements marketed for use with the StageOne™
Shoulder Cement Spacer Molds.
The subject device is a sterile, single use device made of silicone and is
used to create a temporary hemi-shoulder implant component made from
antibiotic bone cement, Refobacin® Bone Cement R. After removal of the
initial implant the prepared cement spacer is placed into the glenohumeral |
| Intended Use: | The StageOne™ Shoulder Cement Spacer Molds are intended to create a temporary hemi-shoulder replacement prosthesis as part of a two-stage revision procedure. |
| Indications for Use: | StageOne™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). |
| | The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period. |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics:
Intended Use: Identical to the predicate device. Indications for Use: The subject device has similar indications for use as the predicate device. The subject device is now indicated for use only with Refobacin® Bone Cement R. There are no changes to the intended clinical use of the device. Materials: The subject device is made of the same raw materials as the predicate device. Design Features: The subject device has the same design features as the predicate device. Variants/Sizes: The subject device has the same variants and sizes as the predicate device. Sterilization Method: Identical to the predicate device. Packaging: The subject device has similar packaging to the predicate device. Both the subject and predicate devices are packaged using a double sterile barrier configuration. |
4
5
Summary of Performance Data (Nonclinical and/or Clinical):
- . Non-Clinical Testing: Non-clinical performance testing was conducted to support the proposed modifications for the subject StageOne™ Shoulder Cement Spacer Molds and establish substantial equivalence between the subject device and the identified predicate. o Biocompatibility Evaluation
- Packaging testing O
- Sterilization Validation о
- Fatigue performance testing O
- Static performance testing O
- o Antibiotic elution testing
- Clinical Testing: Clinical data and conclusions were deemed not . necessary to establish substantial equivalence between the subject StageOne™ Shoulder Cement Spacer Molds and the identified predicate for the proposed device modifications.
The subject device has the same intended use, similar clinical indications for use as the predicate device. There are no changes to the design features, materials, operating principle, shelf-life or sterilization method. The proposed device has similar technological characteristics to the predicate device, and the information provided herein demonstrates that:
- o 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 o marketed predicate device.
Substantial Equivalence Conclusion:
Intended Use / Indications for Use
Stage One™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
Product codes (comma separated list FDA assigned to the subject device)
MBB, HSD, KWS
Device Description
The purpose of this submission is to obtain clearance for the proposed modifications to the manufacturing process, sterile packaging configuration, product labeling, engineering drawings and indications for use regarding bone cements marketed for use with the StageOne™ Shoulder Cement Spacer Molds.
The subject device is a sterile, single use device made of silicone and is used to create a temporary hemi-shoulder implant component made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacer is placed into the glenohumeral
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral medullary canal and glenoidal cavity, glenohumeral
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Testing: Non-clinical performance testing was conducted to support the proposed modifications for the subject StageOne™ Shoulder Cement Spacer Molds and establish substantial equivalence between the subject device and the identified predicate.
o Biocompatibility Evaluation
- Packaging testing O
- Sterilization Validation о
- Fatigue performance testing O
- Static performance testing O
- o Antibiotic elution testing
Clinical Testing: Clinical data and conclusions were deemed not . necessary to establish substantial equivalence between the subject StageOne™ Shoulder Cement Spacer Molds and the identified predicate for the proposed device modifications.
The subject device has the same intended use, similar clinical indications for use as the predicate device. There are no changes to the design features, materials, operating principle, shelf-life or sterilization method. The proposed device has similar technological characteristics to the predicate device, and the information provided herein demonstrates that:
- o 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 o marketed predicate device.
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):
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
September 15, 2022
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 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. Neha Sreenath Regulatory Affairs Senior Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581
Re: K221968
Trade/Device Name: StageOne™ Shoulder Cement Spacer Molds Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: July 1, 2022 Received: July 5, 2022
Dear Neha Sreenath:
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 (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 mediation-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.
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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) K221968
Device Name
StageOne™ Shoulder Cement Spacer Molds
Indications for Use (Describe)
Stage One™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
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)
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 Druq 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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 StageOne™ Shoulder Cement Spacer Molds 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, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581, USA
Establishment Registration Number: 1825034 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neha Sreenath
Regulatory Affairs Senior Specialist
Telephone: (0065-8504 1704) |
| Date: | 01 July 2022 |
| Subject Device: | Trade Name: StageOne™ Shoulder Cement Spacer Molds
Common Name: Temporary Bone Cement Hemi-Shoulder Prosthesis
Classification Name:
• MBB – Polymethylmethacrylate (PMMA) bone cement (21 CFR
888.3027)
• HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented
prosthesis (21 CFR 888.3690)
• KWS - Shoulder joint metal/polymer semi-constrained cemented
prosthesis (21 CFR 888.3660) |
| Predicate Device: | StageOne™ Disposable Cement
Spacer Molds for Temporary Hemi- Biomet, Inc.
K160071
Shoulder Prosthesis |
| Purpose and Device
Description: | The purpose of this submission is to obtain clearance for the proposed
modifications to the manufacturing process, sterile packaging
configuration, product labeling, engineering drawings and indications for
use regarding bone cements marketed for use with the StageOne™
Shoulder Cement Spacer Molds.
The subject device is a sterile, single use device made of silicone and is
used to create a temporary hemi-shoulder implant component made from
antibiotic bone cement, Refobacin® Bone Cement R. After removal of the
initial implant the prepared cement spacer is placed into the glenohumeral |
| Intended Use: | The StageOne™ Shoulder Cement Spacer Molds are intended to create a temporary hemi-shoulder replacement prosthesis as part of a two-stage revision procedure. |
| Indications for Use: | StageOne™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). |
| | The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period. |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of the following characteristics:
Intended Use: Identical to the predicate device. Indications for Use: The subject device has similar indications for use as the predicate device. The subject device is now indicated for use only with Refobacin® Bone Cement R. There are no changes to the intended clinical use of the device. Materials: The subject device is made of the same raw materials as the predicate device. Design Features: The subject device has the same design features as the predicate device. Variants/Sizes: The subject device has the same variants and sizes as the predicate device. Sterilization Method: Identical to the predicate device. Packaging: The subject device has similar packaging to the predicate device. Both the subject and predicate devices are packaged using a double sterile barrier configuration. |
4
5
Summary of Performance Data (Nonclinical and/or Clinical):
- . Non-Clinical Testing: Non-clinical performance testing was conducted to support the proposed modifications for the subject StageOne™ Shoulder Cement Spacer Molds and establish substantial equivalence between the subject device and the identified predicate. o Biocompatibility Evaluation
- Packaging testing O
- Sterilization Validation о
- Fatigue performance testing O
- Static performance testing O
- o Antibiotic elution testing
- Clinical Testing: Clinical data and conclusions were deemed not . necessary to establish substantial equivalence between the subject StageOne™ Shoulder Cement Spacer Molds and the identified predicate for the proposed device modifications.
The subject device has the same intended use, similar clinical indications for use as the predicate device. There are no changes to the design features, materials, operating principle, shelf-life or sterilization method. The proposed device has similar technological characteristics to the predicate device, and the information provided herein demonstrates that:
- o 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 o marketed predicate device.