Disposable cement spacer molds with titanium reinforcement stem and prolongation 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 low viscosity polymethylmethacrylate bone cement 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 SpaceFlex Hip 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 treatmy performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), 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

AI/ML Overview

This document describes the G21 SpaceFlex Hip, a medical device for temporary hemi-hip replacement, and provides information regarding its FDA clearance.

Here's an analysis of the provided text with respect to your questions:

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

The document mentions that the device was tested against "applicable international standards" and that "all results were satisfactory and met all performance specifications." However, it does not provide a specific table of acceptance criteria with corresponding performance outcomes. It lists the types of tests performed:

Test Type	Reported Performance
Fatigue Test	"functioned as intended" and "all results were satisfactory and met all performance specifications."
Gentamicin Elution Test	"functioned as intended" and "all results were satisfactory and met all performance specifications."
Molding Temperature Analysis	"functioned as intended" and "all results were satisfactory and met all performance specifications."
Pyrogen testing (USP 38: NF33 <161>)	Concluded that the "subject device and packaging is non-pyrogenic."

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 mentions "performance testing - mechanical/bench testing," but it does not specify the sample size for any of these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were likely benchtop (laboratory) studies, not human or animal studies.

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)

This question is not applicable to the information provided. The document describes mechanical/bench testing, which typically does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" here would be the physical properties and performance characteristics measured by engineering and scientific methods against established standards.

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

This question is not applicable for the same reasons as point 3. Adjudication methods are relevant for interpretation of clinical data or images, not for objective measurements in bench testing.

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

This question is not applicable. The G21 SpaceFlex Hip is a physical medical device (cement molds for temporary hip replacement), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance are not relevant.

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

This question is not applicable, as the device is a physical medical product, not an algorithm.

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

For the performance testing mentioned, the "ground truth" would be established by engineering and scientific standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility. For instance, the pyrogen testing refers to USP 38: NF33 <161>, which defines the method and acceptance criteria for pyrogenicity.

8. The sample size for the training set

This question is not applicable as the device is a physical product and not an AI algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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.

G21 S.r.l % Barry Sands President ROMIS. Inc. 110 Haverhill Road, Suite #526 Amesbury, Massachusetts 01860

Re: K192041

Trade/Device Name: G21 SpaceFlex Hip Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, KWL, KWY Dated: July 25, 2019 Received: July 31, 2019

Dear Mr. Sands:

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

Laurence D. Coyne, Ph.D. Acting 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K192041

Device Name G21 SpaceFlex Hip

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

G21 S.r.l. 's SpaceFlex Hip K192041

SUBMITTER l.

G21 S.r.l. Via S. Pertini, 8 41039 S. Possidonio (MO) Italy

Phone: +39 0535 30312 Fax: +39 0535 417332

Contact Person: Manjusha Bharadwaj RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: 1-(978) 358-7307 Fax: 1 (978) 477-0206

Date Prepared: 05 April 2019

II. DEVICE

Trade/Device Name:	SpaceFlex Hip
Common or Usual Name:	Bone Cement Spacer Molds for Temporary Hip Replacement
Classification Name:	Bone cement, antibiotic
Regulation Number:	21 CFR 888.3027, 21 CFR 888.3360, 21 CFR 888.3390
Regulatory Class:	Class II
Product codes:	MBB, KWL, KWY

lll. PREDICATE DEVICES

Primary Predicate: StageOne Select Hip Cement Spacer Molds, Biomet, Inc. (K161166)

Additional Predicate: SPACER-G Temporary Hip Prosthesis, Tecres S.p.A. (K031841)

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

Indications for Use / Intended Use:

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 SpaceFlex Hip 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.).

V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological features of the SpaceFlex Hip are similar to the predicates with one difference in the sterilization method. The subject device has the same design, intended use and mode of operation as the predicate and the differences do not lead to new safety or effectiveness issues.

VI. PERFORMANCE DATA

The mechanical properties of the SpaceFlex Hip System were tested in accordance with applicable international standards. In all instances the device functioned as intended and all results were satisfactory and met all performance specifications. The testing performed includes,

1. Fatigue Test
1. Gentamicin Elution Test
1. Molding Temperature Analysis

Pyrogen testing was done in accordance with USP 38: NF33 < 161 > "Medical Devices – Bacterial Endotoxins and Pyrogen Tests". The bacterial endotoxins verification tests concluded that the subject device and packaging is non-pyrogenic.

{5}------------------------------------------------

VII. CONCLUSION

The SpaceFlex Hip disposable cement spacer is substantially equivalent to other legally marketed cement spacers indicated for use to mold a temporary total hip replacement. The SpaceFlex Hip has the same general intended use and substantially the same indications for use, technological characteristics, and principles of operation as the previously cleared primary predicate, Biomet Inc.'s StageOne Select Hip Cement Spacer Molds (K161166) and additional predicate, Tecres S.p.A.'s SPACER-G Temporary Hip Prosthesis (K031841).

The substantial equivalence discussion included in the submission demonstrates the substantial equivalence of the SpaceFlex Hip System (the subject device) and its predicate devices as well as describing the minor differences in the technological characteristics, which do not raise any new questions of safety or efficacy. The performance testing - mechanical/bench testing - as well as the same indications for use demonstrate that the SpaceFlex Hip system is as safe and effective as its 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.”