(336 days)
Not Found
No
The summary describes a physical mold used to create temporary knee spacers from bone cement. 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 total knee replacement for patients undergoing a two-stage revision procedure due to a septic process, which is a therapeutic intervention.
No
Explanation: The device is used to mold a temporary knee replacement during a two-stage revision procedure for septic processes. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition, but rather is used in the treatment of a condition.
No
The device description explicitly states it is a sterile, single-use device made of silicone, which is a physical material used to mold a temporary prosthesis. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The StageOne™ Knee Cement Spacer Molds are used to create a physical, temporary implant that is placed inside the patient's knee joint. It is a surgical device used in vivo (within the living body).
- Intended Use: The intended use is to mold a temporary knee replacement for patients undergoing a two-stage revision procedure due to infection. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device description and intended use clearly indicate that this is a surgical implant molding tool, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
StageOne™ Knee Cement Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) 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 joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The knee prosthesis made from the StageOne™ Knee 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 (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the knee prosthesis material (Refobacin® Bone Cement R), the temporary knee prosthesis is only indicated for patients who will consistently use traditional mobility devices (e.g. crutches, walkers) throughout the implant period.
Product codes (comma separated list FDA assigned to the subject device)
MBB, JWH
Device Description
The subject device is a sterile, single use device made of silicone and is used to create temporary tibial and femoral implant components made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacers are placed into the tibiofemoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary spacers remain in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional knee joint prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint space / tibiofemoral joint space
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 Testing: Nonclinical performance testing was conducted to support the proposed modifications for the subject StageOne™ Knee Cement Spacer Molds and establish substantial equivalence between the subject device and identified predicate device.
- Biocompatibility Evaluation
- Packaging testing
- Sterilization Validation
- Wear testing
- Antibiotic elution testing
Clinical Testing: Clinical data was not required to establish substantial equivalence between the subject StageOne Knee Cement Spacer Molds and the identified predicate device for the proposed device modifications.
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.”
0
September 2, 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 and 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 Senior Specialist, Regulatory Affairs 56 East Bell Drive Warsaw. Indiana 46581
Re: K213287
Trade/Device Name: StageOne™ Knee Cement Spacer Molds Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: MBB, JWH Dated: August 5, 2022 Received: August 8, 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
1
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 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,
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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213287
Device Name
StageOne™ Knee Cement Spacer Molds
Indications for Use (Describe)
StageOne™ Knee Cement Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) 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 joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The knee prosthesis made from the StageOne™ Knee 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 (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the knee prosthesis material (Refobacin® Bone Cement R), the temporary knee prosthesis is only indicated for patients who will consistently use traditional mobility devices (e.g. crutches, walkers) 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)
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3
510(k) Number: K213287 Dated: August 31, 2022
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™ Knee 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 SeniorSpecialist
Telephone: (0065 6854 7227) |
| Date: | August 31, 2022 |
| Subject Device: | Trade Name: StageOne™ Knee Cement Spacer Molds
Common Name: Temporary Bone Cement Knee Prosthesis
Classification Name:
• MBB – Polymethylmethacrylate (PMMA) bone cement (21 CFR
888.3027)
• JWH – Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (21 CFR 888.3560) |
| Predicate Device: | K161273 StageOne Disposable Cement Spacer
Molds for Temporary Knee Prosthesis Biomet, Inc. |
| 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 Knee
Cement Spacer Molds.
The subject device is a sterile, single use device made of silicone and is
used to create temporary tibial and femoral implant components made
from antibiotic bone cement, Refobacin® Bone Cement R. After removal
of the initial implant the prepared cement spacers are placed into the
tibiofemoral joint space using Refobacin® Bone Cement R as the first
stage of a two-stage revision surgical procedure. The temporary spacers
remain in place (180 days or less) until the second stage of the two-stage
revision procedure is performed to implant a conventional knee joint
prosthesis. |
| Intended Use: | The StageOne Knee Cement Spacer Molds are intended to create a
temporary knee replacement prosthesis as part of a two-stage revision
procedure. |
| Indications for Use: | StageOne™ Knee Cement Spacer Molds are indicated for use to mold a
temporary total knee replacement (TKR) 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 joint space following removal of the existing total knee
replacement implants and debridement. The device is intended for use in
conjunction with systemic antimicrobial antibiotic therapy (standard
treatment approach to an infection). |
| | The knee prosthesis made from the StageOne™ Knee 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 knee prosthesis material
(Refobacin® Bone Cement R), the temporary knee prosthesis is only
indicated for patients who will consistently use traditional mobility
devices (e.g. crutches, walkers) 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: The subject device is sterilized using the same
sterilization method as the predicate device.
● Manufacturing Process: The subject device is manufactured using a
manufacturing process similar to the predicate device.
● Packaging: The subject device has similar packaging as the predicate
device; both the subject and predicate devices are packaged in a
double sterile barrier configuration. |
4
5
Summary of Performance Data (Nonclinical and/or Clinical):
● Non-Clinical Testing: Nonclinical performance testing was conducted to support the proposed modifications for the subject StageOne™ Knee Cement Spacer Molds and establish substantial equivalence between the subject device and identified predicate device.
- Biocompatibility Evaluation o
- Packaging testing O
- Sterilization Validation O
- Wear testing O
- Antibiotic elution testing O
- Clinical Testing: Clinical data was not required to establish ● substantial equivalence between the subject StageOne Knee Cement Spacer Molds and the identified predicate device 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:
- Any differences do not raise new questions of safety and O effectiveness; and
- The proposed device is at least as safe and effective as the legally O marketed predicate device.
Substantial Equivalence Conclusion: