(135 days)
Not Found
No
The device description and intended use focus on the physical components and materials used to create a temporary hip prosthesis. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are focused on mechanical and elution characteristics, not algorithmic performance.
Yes
The device is used to mold a temporary hemi-hip replacement in patients undergoing a two-stage revision procedure due to a septic process, and is intended for use in conjunction with systemic antimicrobial antibiotic therapy, which indicates a therapeutic purpose.
No
This device is a temporary hemi-hip replacement used in a two-stage revision procedure for septic processes, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a single-use, sterile disposable made of medical grade silicone with a 316L stainless steel reinforcement stem, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is a mold used to create a temporary hip prosthesis that is implanted directly into the patient's body. It is a surgical implant/tool, not a device that analyzes biological samples.
- Intended Use: The intended use is to mold a temporary hip replacement for patients undergoing a two-stage revision procedure due to infection. This is a therapeutic and surgical application, not a diagnostic one.
Therefore, this device falls under the category of a medical device used for surgical and therapeutic purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable cement spacer molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip 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. assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-hip prosthesis made from the StageOne™ Select 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-hip prosthesis material (PALACOS® R+G Bone and Refobacin® Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Product codes (comma separated list FDA assigned to the subject device)
MBB, KWY, KWL
Device Description
The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. 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-hip prosthesis is to be removed from the molds with the reinforcement remaining as the core of the hemi-hip prosthesis, assembled using the neck length adapter and placed into the joint space. The hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral medullary canal and acetabular 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
o Mechanical performance testing and Gentamicin Elution testing of StageOne™ Select Hip 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™ Select Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R possess mechanical and elution characteristics equivalent to those of the predicate device. Bacterial endotoxin testing (BET) demonstrates that StageOne™ Select Hip Spacer Molds meet pyrogen limit specifications.
Clinical Tests
o Clinical data was not required to establish substantial equivalence between the subject StageOne™ Select Hip Spacer Molds and the 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): 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
§ 888.3027 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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
Biomet, Inc. Ms. Heidi Busz Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581
Re: K161166
Trade/Device Name: StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, KWY, KWL Dated: August 2, 2016 Received: August 3, 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mark N. Melkerson -S
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
510(k) Number (if known)
K161166
Device Name
StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem
Indications for Use (Describe)
Disposable cement spacer molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip 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. assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-hip prosthesis made from the StageOne™ Select 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-hip prosthesis material (PALACOS® R+G Bone and Refobacin® Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. A horizontal line is placed directly underneath the word, spanning its entire width.
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™ Select Hip 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: | August 2, 2016 |
| Subject Device: | Trade Name: StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement
Common Name: Bone Cement Spacer Mold; Disposable Cement Spacer Molds for Temporary Hip Prosthesis; StageOne™ Select Hip Spacer Molds
Classification Name:
KWY- Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390) KWL-Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360) MBB-Polymethylmethacrylate (PMMA) bone cement (21 CFR 888.3027) |
Legally marketed devices to which substantial equivalence is claimed:
- K080979-StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement ●
Device Description
The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. 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-hip prosthesis is to be removed from the molds with the reinforcement remaining as the core of the hemi-hip prosthesis, assembled using the neck length adapter and placed into the joint space. The hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.
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Image /page/4/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 dark gray, and the background is white. The word appears to be a logo or brand name.
Indications for Use
Disposable cement spacer molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip 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*, assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-hip prosthesis made from the StageOne Select 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-hip prosthesis material (PALACOS® R+G Bone Cement and Refobacin® Bone Cement R*), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) 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™ Select Hip Spacer Mold design features, materials, sizes, sterilization method, manufacturing process, sterility assurance level, or shelf life of the StageOne™ Select Hip Spacer Molds.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- o Mechanical performance testing and Gentamicin Elution testing of StageOne™ Select Hip 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™ Select Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R possess mechanical and elution characteristics equivalent to those of the predicate device. Bacterial endotoxin testing (BET) demonstrates that StageOne™ Select Hip Spacer Molds meet pyrogen limit specifications.
- Clinical Tests
- o Clinical data was not required to establish substantial equivalence between the subject StageOne™ Select Hip 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
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BIOMET
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.