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.

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.

AI/ML Overview

This document describes the StageOne™ Knee Cement Spacer Molds, a device used to mold temporary total knee replacements in a two-stage revision procedure due to a septic process.

Here's an analysis based on your request:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical performance tests conducted to support the modifications and establish substantial equivalence to a predicate device. The underlying assumption is that the device met the acceptance criteria for these tests, as the FDA concluded substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility	Passed (Biocompatibility Evaluation completed)
Packaging integrity and sterility maintenance	Passed (Packaging testing completed, double sterile barrier configuration)
Sterilization effectiveness	Passed (Sterilization Validation completed, same method as predicate)
Wear characteristics (relevant to temporary use)	Passed (Wear testing completed)
Antibiotic elution properties (as it uses antibiotic bone cement)	Passed (Antibiotic elution testing completed)
Overall Safety and Effectiveness	Differences do not raise new questions of safety and effectiveness; at least as safe and effective as the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document focuses on non-clinical performance testing. Therefore, there is no patient-specific test set sample size or provenance information (country of origin, retrospective/prospective) for clinical data provided. The testing relates to the physical and chemical properties of the device and its molded cement.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since this is a non-clinical device, there were no clinical experts used to establish ground truth for a test set in the traditional sense (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been based on established standards, protocols, and scientific principles followed by engineers, material scientists, and microbiologists involved in the testing. The document does not specify the number or specific qualifications of these individuals, but it's understood that qualified personnel would conduct such tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method was used for a test set because this was entirely non-clinical testing. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a cement spacer mold, not an AI or imaging-related device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" was established by recognized industry standards, scientific principles, and internal specifications for biocompatibility, packaging, sterilization, wear, and antibiotic elution. For example, biocompatibility testing would adhere to ISO 10993 standards, and sterilization validation would follow established guidelines to ensure a certain sterility assurance level (SAL).

8. The sample size for the training set

There is no "training set" as this is a physical medical device and not a machine learning model.

9. How the ground truth for the training set was established

As there is no training set, this question is not applicable.

Summary

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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

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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

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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)

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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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 DriveP.O. Box 587Warsaw, Indiana 46581, USAEstablishment Registration Number: 1825034
Contact Person:	Neha SreenathRegulatory Affairs SeniorSpecialistTelephone: (0065 6854 7227)
Date:	August 31, 2022
Subject Device:	Trade Name: StageOne™ Knee Cement Spacer MoldsCommon Name: Temporary Bone Cement Knee ProsthesisClassification Name:• MBB – Polymethylmethacrylate (PMMA) bone cement (21 CFR888.3027)• JWH – Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560)
Predicate Device:	K161273 StageOne Disposable Cement SpacerMolds for Temporary Knee Prosthesis Biomet, Inc.
Purpose and DeviceDescription:	The purpose of this submission is to obtain clearance for the proposedmodifications to the manufacturing process, sterile packagingconfiguration, product labeling, engineering drawings and indications foruse regarding bone cements marketed for use with the StageOne KneeCement Spacer Molds.The subject device is a sterile, single use device made of silicone and isused to create temporary tibial and femoral implant components madefrom antibiotic bone cement, Refobacin® Bone Cement R. After removalof the initial implant the prepared cement spacers are placed into thetibiofemoral joint space using Refobacin® Bone Cement R as the firststage of a two-stage revision surgical procedure. The temporary spacersremain in place (180 days or less) until the second stage of the two-stagerevision procedure is performed to implant a conventional knee jointprosthesis.
Intended Use:	The StageOne Knee Cement Spacer Molds are intended to create atemporary knee replacement prosthesis as part of a two-stage revisionprocedure.
Indications for Use:	StageOne™ Knee Cement Spacer Molds are indicated for use to mold atemporary total knee replacement (TKR) for skeletally mature patientsundergoing a two-stage revision procedure due to a septic process. Thetemporary prosthesis is molded using Refobacin® Bone Cement R andinserted into the joint space following removal of the existing total kneereplacement implants and debridement. The device is intended for use inconjunction with systemic antimicrobial antibiotic therapy (standardtreatment approach to an infection).
	The knee prosthesis made from the StageOne™ Knee Cement SpacerMolds is not intended for use more than 180 days, at which time it mustbe explanted and permanent devices implanted or another appropriatetreatment 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 onlyindicated for patients who will consistently use traditional mobilitydevices (e.g. crutches, walkers) throughout the implant period.
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based on consideration of thefollowing characteristics:● Intended Use: Identical to the predicate device.● Indications for Use: The subject device has similar indications foruse as the predicate device. The subject device is now indicated foruse only with Refobacin® Bone Cement R. There are no changes tothe intended clinical use of the device.● Materials: The subject device is made of the same raw materials asthe predicate device.● Design Features: The subject device has the same design features asthe predicate device.● Variants/Sizes: The subject device has the same variants and sizes asthe predicate device.● Sterilization Method: The subject device is sterilized using the samesterilization method as the predicate device.● Manufacturing Process: The subject device is manufactured using amanufacturing process similar to the predicate device.● Packaging: The subject device has similar packaging as the predicatedevice; both the subject and predicate devices are packaged in adouble sterile barrier configuration.

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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:

Regulation Number and Section

§ 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.”