The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin or gentamicin vancomycin are the most appropriate antibiotics based on the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medulary canal and can mate directly with the native actabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

Device Description

The OsteoRemedies Hip Spacer System is a modular temporary spacer device inclusive of femoral stems, femoral heads, and acetabular cups. The OsteoRemedies Hip Spacer System is sterile and single-use, intended for temporary use (maximum 180 days) for joint replacement. This submission expands the existing system to include additional sizes of the acetabular cup and femoral head. The system components are made of fully formed polymethylmethacrylate (PMMA) with gentamicin (REMEDY®) and gentamicin with vancomycin (REMEDY SPECTRUM® GV).

The OsteoRemedies Hip Spacer System provides a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The REMEDY® components are protected from bacterial adhesion due to the presence of gentamicin. The REMEDY SPECTRUM® GV components are protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

AI/ML Overview

This document is a 510(k) premarket notification for the OsteoRemedies Hip Spacer System, specifically focusing on expanding the system to include additional sizes of acetabular cups and femoral heads (XS REMEDY Modular Head, XS REMEDY SPECTRUM GV Modular Head, and XS REMEDY Acetabular Cup). This document does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for this medical device, with N/A for fields not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Stem fatigue (ISO 7206-4)	(Implicit: Meet relevant ISO 7206-4 standards for hip implants, demonstrating acceptable fatigue life under specified loads)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Neck fatigue (ISO 7206-6)	(Implicit: Meet relevant ISO 7206-6 standards for hip implants, demonstrating acceptable fatigue life under specified loads)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Femoral head/stem disassembly (ISO 7206-13)	(Implicit: Meet relevant ISO 7206-13 standards for hip implants, demonstrating acceptable resistance to disassembly)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Chemical and physical properties of cement	(Implicit: Meet established standards for PMMA bone cement, likely including mechanical strength, setting time, and other critical properties.)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Antibiotic elution kinetics	(Implicit: Demonstrate appropriate and sustained release of gentamicin, and gentamicin with vancomycin, to achieve therapeutic levels for the indicated duration, as per established clinical effectiveness requirements for antibiotic-loaded spacers.)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Biocompatibility data	(Implicit: Demonstrate that device materials are biocompatible and do not elicit adverse biological responses as per ISO 10993 series for medical devices in contact with tissue.)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Sterilization, pyrogenicity, bacterial endotoxin, and shelf life testing	(Implicit: Demonstrate device sterility, absence of pyrogens/endotoxins, and maintenance of product integrity and function throughout its claimed shelf-life, per relevant ISO standards and FDA guidance.)	Performed on predicate devices; applicable to subject components. (Specific performance data not provided in this summary, but presumed to meet standards based on substantial equivalence claim.)
Static and fatigue strength of the resin	(Implicit: Meet internal or industry standards for the PMMA resin used in the device components, ensuring adequate mechanical integrity.)	Analyses performed on XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support substantial equivalence. (Specific performance data not provided.)
Fatigue strength of the head/stem construct	(Implicit: Meet internal or industry standards for the combined head and stem assembly, ensuring adequate mechanical integrity.)	Analyses performed on XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support substantial equivalence. (Specific performance data not provided.)
Range of motion	(Implicit: Demonstrate that the new smaller components allow for a functional range of motion, similar to or better than predicate devices.)	Analyses performed on XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support substantial equivalence. (Specific performance data not provided.)
Risk of dislocation	(Implicit: Demonstrate that the new smaller components do not increase the risk of dislocation compared to predicate devices, considering design and geometric factors.)	Analyses performed on XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support substantial equivalence. (Specific performance data not provided.)
Surface roughness and wear	(Implicit: Demonstrate that the surface properties and wear characteristics of the new components are acceptable and comparable to predicate devices to minimize friction and wear in the joint.)	Analyses performed on XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support substantial equivalence. (Specific performance data not provided.)
Antibiotic content	(Implicit: The extra-small head and cup components contain less antibiotics than larger, previously cleared components while maintaining clinical efficacy parameters for antibiotic release. This implies an acceptance criterion for the effective concentration and elution profile of antibiotics within the smaller volume.)	The extra-small head and cup components contain less antibiotics than larger, previously cleared components of the OsteoRemedies Hip Spacer System. (Specific quantitative details not provided.)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests within this summary document. For mechanical testing (fatigue, disassembly), standard practices involve testing a statistically representative number of samples for each design variant to ensure robustness. For antibiotic elution, multiple samples would also be tested.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies are primarily lab-based performance tests for mechanical properties and material characteristics. Clinical data is mentioned as having been performed on "predicate devices," implying existing data. The context is a US FDA submission, so industry standards are applied. Retrospective or prospective is not applicable for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This document describes engineering performance testing and material characterization, not studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment. The "ground truth" for these tests is defined by established engineering and material science standards (e.g., ISO, ASTM).

4. Adjudication method for the test set:

N/A. As above, this is not an AI/ML clinical validation study involving human interpretation and adjudication. The tests involve objective measurements against predefined criteria.

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:

N/A. This device is a physical hip spacer, not an AI/ML software device.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Engineering Standards and Material Specifications: For mechanical properties (fatigue, strength, disassembly, wear, range of motion), the ground truth is established by recognized international standards (e.g., ISO 7206 series) and material specifications for PMMA.
Biocompatibility Standards: For biocompatibility, the ground truth is established by ISO 10993 series.
Pharmacokinetic/Pharmacodynamic Principles: For antibiotic elution kinetics, the ground truth is based on established principles of drug release and achieving therapeutic concentrations, typically supported by in vitro or in vivo studies on the predicate device.
Sterilization Validation Standards: For sterility, pyrogenicity, and endotoxin, the ground truth is established by relevant sterilization and quality control standards.

8. The sample size for the training set:

N/A. This is not an AI/ML device, so there is no "training set."

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

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

Summary

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January 10, 2020

OsteoRemedies, LLC % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA. LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K192995

Trade/Device Name: OsteoRemedies Hip Spacer System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWL. KWY Dated: December 10, 2019 Received: December 11, 2019

Dear Ms. Rhodes:

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

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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 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 medical devices and radiation-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. Acting 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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Indications for Use

510(k) Number (if known) K192995

Device Name

OsteoRemedies Hip Spacer System

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) Summary

Submitter:	OsteoRemedies, LLC6800 Poplar Avenue, #120Memphis, TN 38138Phone: (901) 453-3141Email: info@osteoremedies.com
Official Correspondent:	Ms. Hollace Saas RhodesVice President, Orthopedic Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5807Email: hrhodes@mcra.com
Date Prepared:	January 10, 2020
Trade Names:	OsteoRemedies Hip Spacer System:- REMEDY® Modular Head 40mm,- REMEDY SPECTRUM® GV Modular Femoral Head – 40mm,- REMEDY® Acetabular Cup 40mm ID/48mm OD
Common Name:	Temporary femoral head and acetabular cup spacer with antibiotic
Classification:	Class II
Regulation:	21 CFR 888.3360, Hip joint femoral (hemi-hip) metallic cementedor uncemented prosthesis
Product Codes:	KWL KWY

Subject & Predicate Devices:

Subject Devices	Predicate Devices
XS REMEDY Modular Head	REMEDY Hip Spacer (K112470) – Originally cleared under thetrade name, 2GC Hip/Knee Modular Spacer
XS REMEDY SPECTRUM GVModular Head	REMEDY SPECTRUM GV Hip Spacer (K172906) – Originallycleared under the trade name, REMEDY PLUS Hip Spacer
XS REMEDY Acetabular Cup	REMEDY Acetabular Cup (K191981 and K173967)

The subject devices are substantially equivalent to the previously cleared components of the OsteoRemedies Hip Spacer System with respect to intended use, materials, design, and function. The information summarized in the Design Control Activities Summary demonstrates that the subject components met the pre-determined acceptance criteria for the verification activities.

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Device Description:

Indications for Use:

The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabular or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

Performance Testing:

The following testing was performed on the predicate devices and is applicable to the subject components of the OsteoRemedies Hip Spacer System:

Stem fatigue per ISO 7206-4 ●
Neck fatigue per ISO 7206-6 ●

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Femoral head/stem disassembly based on ISO 7206-13
Chemical and physical properties of cement ●
Antibiotic elution kinetics ●
Clinical data ●
o Biocompatibility data
Sterilization, pyrogenicity, bacterial endotoxin, and shelf life testing ●

Substantial Equivalence:

Analyses of static and fatigue strength of the resin, fatigue strength of the head/stem construct, range of motion, risk of dislocation, surface roughness, and wear were performed on the XS REMEDY Head, XS REMEDY SPECTRUM GV Head, and XS REMEDY Acetabular Cup to support their substantial equivalence. In addition, the extra-small head and cup components contain less antibiotics than larger, previously cleared components of the OsteoRemedies Hip Spacer System.

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.