(155 days)
Not Found
No
The device description and intended use focus on physical molds for creating temporary cement spacers. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used to mold a temporary hemi-shoulder replacement, which is inserted into the body to treat a septic process in skeletally mature patients undergoing a two-stage revision procedure. This makes it a therapeutic device.
No
The device is described as a mold for creating a temporary hemi-shoulder prosthesis, intended for a two-stage revision procedure due to a septic process. Its function is to hold bone cement to form an implant, not to diagnose a medical condition.
No
The device description clearly states it is a physical, single-use, sterile disposable mold made of medical grade silicone, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is a mold used to create a temporary physical implant (a cement spacer) that is placed inside the patient's body. It is a surgical device used in a revision procedure.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. Its function is purely mechanical and structural within the body.
Therefore, the disposable cement spacer molds fall under the category of a medical device used in a surgical procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable 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 Palacos® R+G Bone Cement or 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 antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the StageOne™ disposable cement 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 (Palacos® R-G Bone Cement and 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
MBB, HSD, KWS
Device Description
The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are intended to be filled with Palacos® R+G Bone Cement or Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.
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
Indicated Patient Age Range
skeletally mature patients
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:
Mechanical performance testing and Gentamicin Elution testing of StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical and elution characteristics comparable to those of the predicate device. Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use.
Clinical Tests:
Clinical data was not required to establish substantial equivalence between the subject StageOne™ Shoulder Spacer Molds and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected or overlapping. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2016
Biomet, Incorporated Ms. Heidi Busz Global Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581
Re: K160071
Trade/Device Name: StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: April 15, 2016 Received: April 18, 2016
Dear Ms. Busz:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160071
Device Name
StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Indications for Use (Describe)
Disposable 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 Palacos® R+G Bone Cement or 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 antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the StageOne™ disposable cement 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 (Palacos® R-G Bone Cement and 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.
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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:
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Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, contrasting with the white background. The overall impression is clean and professional.
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 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 on August 12, 2005
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Heidi Busz
Regulatory Affairs Associate |
| Phone: | 574-372-4249 |
| Fax: | 574-372-4710 |
| Date: | May 31, 2016 |
| Subject Device: | Trade Name: StageOne™ Disposable Cement Spacer Molds for
Temporary Hemi-Shoulder Prosthesis
Common Name: Bone Cement Shoulder Spacer Mold; Disposable
Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis;
StageOne™ Shoulder Spacer Mold |
| 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) |
Legally marketed devices to which substantial equivalence is claimed:
- K131135-StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ● Prosthesis
- K112983-Tecres S.p.A. InterSpace® Shoulder
Device Description
The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are intended to be filled with Palacos® R+G Bone Cement or Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.
Indications for Use
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Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a sans-serif font. The letters are all capitalized and appear to be a dark gray color. The letters are evenly spaced and the word is centered in the image. The overall impression is clean and professional.
Disposable 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 Palacos® R+G Bone Cement or 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 the StageOne™ disposable cement 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 (Palacos® R+G Bone Cement and 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 subject modifications include the removal Cobalt™ G-HV Bone Cement from the Instructions for Use and the addition of Palacos® R+G Bone Cement and Refobacin® Bone Cement R for use with the subject device.
The subject modification does not result in any changes to the StageOne™ Shoulder Spacer Mold design features, materials, sizes, sterilization method, manufacturing process, sterility assurance level, or shelf life of the StageOne™ Shoulder Spacer Molds.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- Mechanical performance testing and Gentamicin Elution testing of StageOne™ o Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical and elution characteristics comparable to those of the predicate device. Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use.
- Clinical Tests
- o Clinical data was not required to establish substantial equivalence between the subject StageOne™ Shoulder Spacer Molds and the predicate device.
Substantial Equivalence Conclusion
Based on the similarities in design, function, indications for use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.