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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device.

The "acceptance criteria" discussed in this document revolve around the concept of "substantial equivalence" to a legally marketed predicate device (K080979 - StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement). The study described is a non-clinical performance comparison to demonstrate this equivalence.

Here's the information broken down based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as demonstrated by non-clinical tests)
Mechanical Performance: Equivalent to the predicate device when fabricated with specified bone cements.	StageOne™ Select Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R possess mechanical characteristics equivalent to those of the predicate device.
Gentamicin Elution: Equivalent to the predicate device when fabricated with specified bone cements.	Gentamicin Elution testing of StageOne™ Select Hip Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R demonstrated elution characteristics equivalent to those of the predicate device.
Pyrogen Limit Specifications: Meet pyrogen limit specifications.	Bacterial endotoxin testing (BET) demonstrates that StageOne™ Select Hip Spacer Molds meet pyrogen limit specifications.
Design, Function, Indications for Use, and Fundamental Scientific Technology: Similar to the predicate device.	The submission states: "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." (This is a conclusion based on the overall submission, not a single test result).
Safety and Efficacy: No new risks introduced compared to the predicate device.	The submission concludes that the devices "do not introduce any new risks of safety or efficacy."
No changes to: Design features, materials, sizes, sterilization method, manufacturing process, sterility assurance level, or shelf life of the StageOne™ Select Hip Spacer Molds (other than the specified bone cement changes).	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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for the mechanical performance testing, gentamicin elution testing, or bacterial endotoxin testing. It only states that these tests were performed and demonstrated equivalence.

The data provenance is not explicitly detailed beyond being "Non-Clinical Tests" presented by Biomet Inc. It is retrospective in the sense that it's a comparison to existing, defined characteristics of a predicate device. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission relies on non-clinical comparative testing against a predicate device and established specifications (like pyrogen limits). There is no mention of experts being used to establish ground truth for a test set in the context of diagnostic accuracy or similar applications.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no diagnostic test set with human interpretation requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC study. The device is a physical medical device (spacer molds), not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the non-clinical tests performed are "standalone" in that they assess the physical characteristics and performance of the device itself (or the prosthesis molded from it) against predefined specifications and a predicate device, without direct human interaction as part of the "performance" measurement. However, this is not an "algorithm-only" standalone performance as typically discussed for AI devices.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

Predicate Device Performance: The established mechanical and elution characteristics of the legally marketed predicate device (K080979).
Established Specifications: Pyrogen limit specifications for bacterial endotoxin testing.
Material Properties: The known properties of PALACOS® R+G Bone Cement and Refobacin® Bone Cement R.

8. The Sample Size for the Training Set

Not applicable. This is a medical device for physical implantation, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

Summary

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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

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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)

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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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 DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Heidi BuszRegulatory 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 ReplacementCommon Name: Bone Cement Spacer Mold; Disposable Cement Spacer Molds for Temporary Hip Prosthesis; StageOne™ Select Hip Spacer MoldsClassification 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

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K161166

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.

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.”