← Product Code [QZZ](/submissions/OR/de-novo-classifications/QZZ) · K252920 # ELEOS™ Limb Salvage System with NanoCept® Technology (K252920) _Onkos Surgical, Inc. · QZZ · Oct 15, 2025 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/de-novo-classifications/QZZ/K252920 ## Device Facts - **Applicant:** Onkos Surgical, Inc. - **Product Code:** [QZZ](/submissions/OR/de-novo-classifications/QZZ.md) - **Decision Date:** Oct 15, 2025 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3900 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications; 3) Metastatic diseases The ELEOS™ Limb Salvage System with NanoCept® Technology MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body. ## Device Story Limb salvage system for joint reconstruction; consists of cobalt-chromium (CoCr) implants; features NanoCept® technology, a covalently bound 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB) quaternary ammonium compound coating. Coating applied to proximal tibia components; functions to reduce bacterial contamination on device surface prior to implantation by killing bacteria deposited from operating room environment. Not intended to act in or on patient body; does not treat existing infections. Used by orthopedic surgeons in surgical settings for limb salvage and joint replacement. Benefits patient by reducing pre-implantation bacterial load on implant surface. ## Clinical Evidence No clinical data provided. Performance supported by fretting and corrosion engineering analysis, coating integrity rationale, and biocompatibility risk assessment. ## Technological Characteristics Cobalt-chromium (CoCr) substrate; surface modified with 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB) quaternary ammonium compound coating. Mechanical limb salvage system; non-active. Sterilization and packaging consistent with predicate devices. ## Regulatory Identification A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device, intended to reduce microbial contamination on the surface of the device prior to implantation. ## Special Controls In combination with the general controls of the FD&C Act. the limb and joint salvage device with quaternary ammonium compound coating is subject to the following special controls: - (1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Animal testing must include imaging, histology. and histomorphometry to assess bone formation, healing, and tissue response at relevant timepoints over the course of healing. - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following: - Evaluation of the static and dynamic performance of the implant: (i) - Evaluation of coated implant initial fixation: (ii) - Evaluation of coating integrity: (iii) - Evaluation of range of motion; (iv) - Evaluation of articulating bearing wear and bearing material; (v) - Evaluation of implant disassembly: (vi) - (vii) Evaluation of fretting and corrosion; - (viii) Evaluation of antimicrobial performance with clinically relevant microbial species; and - (ix) Coating characterization, including a detailed description of the substrate morphology and coating process and an evaluation of coating physicochemical properties such as density, thickness, chemistry, and uniformity. - (3) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. - (4) An analysis or information must be provided to support that the antimicrobial does not act within or on the body. - (5) The patient-contacting components of the device must be demonstrated to be biocompatible. - (6) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile. - Performance data must validate the reprocessing instructions for the reusable (7) instrumentation to be used with the device. - Performance data must support the shelf life of the device by demonstrating continued (8) sterility, package integrity, and device functionality over the identified shelf life. - (9) Labeling must include the following: - Identification of device materials; (i) - A shelf life: and (ii) - (iii) Instructions for removal/revision procedures. ## Predicate Devices - ELEOSx™ Limb Salvage System ([DEN210058](/device/DEN210058.md)) - ELEOS™ Limb Salvage System ([K161520](/device/K161520.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION October 15, 2025 Onkos Surgical, Inc. Elizabeth Rose Regulatory Affairs Contractor 77 East Halsey Road Parsippany, New Jersey 07054 Re: K252920 Trade/Device Name: ELEOS™ Limb Salvage System with NanoCept® Technology Regulation Number: 21 CFR 888.3900 Regulation Name: Limb And Joint Salvage Device With Quaternary Ammonium Compound Coating Regulatory Class: Class II Product Code: QZZ, KRO Dated: September 12, 2025 Received: September 12, 2025 Dear Elizabeth Rose: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252920 - Elizabeth Rose Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K252920 - Elizabeth Rose Page 3 Sincerely, RYAN TROMBETTA -S For: Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252920 | | | Device Name ELEOS™ Limb Salvage System with NanoCept® Technology | | | Indications for Use (Describe) The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications; 3) Metastatic diseases The ELEOS™ Limb Salvage System with NanoCept® Technology MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body. 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." | | {4} K252920 Page 1 of 3 # 510(k) Summary Date Prepared: October 15, 2025 Applicant: Onkos Surgical, Inc 77 East Halsey Road Parsippany, NJ 07054 Establish Registration Number: 2184009 Contact Person: Arley Perez Senior Director, Product Development Phone: 239-216-0701 Email: APerez@onkossurgical.com Elizabeth Rose Regulatory Affairs Phone: 423-252-9924 Email: erose@onkossurgical.com Trade Name: ELEOS™ Limb Salvage System with NanoCept® Technology Common Name: Limb and joint salvage device with quaternary ammonium compound coating Classification Name: Limb And Joint Salvage Device with Coating for Bacteria Reduction Classification: Class II (with special controls) Regulation Number: 21 CFR 888.3900 Product Code: QZZ, KRO Primary Predicate: ELEOSx™ Limb Salvage System Submission Number: DEN210058 Additional Predicate: ELEOS™ Limb Salvage System Submission Number: K161520 # Device Description The Onkos Surgical ELEOS™ Limb Salvage System, a reconstruction implant system intended for joint replacement, limb salvage, and restoration of limb function. The subject technology consists of 510(k)-cleared limb salvage systems (i.e., ELEOS™ Limb Salvage System) and applies an antibacterial coating to certain cobalt chromium (CoCr) components. {5} K252920 Page 2 of 3 The ELEOS™ Limb Salvage System with NanoCept® Technology includes components that have been modified with an antibacterial coating, which includes a covalently bound Quaternary Ammonium Compound (QAC), specifically 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB). The purpose of the antibacterial coating is to reduce bacterial contamination on the surface of the device prior to implantation, by killing bacteria external to the patient which deposit onto the device surface from the operating environment. This coating is not intended to act in or on the body of the patient but rather reduces contamination on the surface of the device prior to implantation. The purpose of this 510(k) submission is to introduce the ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia component of the Proximal Tibia assembly) manufactured with cobalt-chromium (CoCr) substrate material cleared in the original predicate device K161520 with an added MDPB coating used in the predicate ELEOSx™ Limb Salvage System DEN210058. This modification aims to expand the product portfolio by adding a CoCr proximal tibia with MDPB coating. ## Indications for Use The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. The ELEOS™ and ELEOS™ Limb Salvage System with NanoCept® Technology is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total femur, distal femur, and proximal tibia is required with the following conditions: 1) Patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) Surgical intervention for severe trauma, revision hip or knee arthroplasties, and/or Oncology indications; 3) Metastatic diseases The ELEOS™ Limb Salvage System with NanoCept® Technology MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body. ## Technological Comparison to Predicate The subject device is substantially equivalent to the predicate device as the subject device shares the same intended use—limb salvage and joint reconstruction—and operating principle, design, {6} K252920 Page 3 of 3 materials, geometry, manufacturing, sterilization and packaging. The modification to apply the MDPB coating to the proximal tibia component of the proximal tibia assembly does not introduce new risks related to mechanical performance, coating characterization, or antibacterial efficacy. ## Performance Data No performance testing was conducted; however, this submission includes supporting information that demonstrates the subject device's performance: - Fretting and Corrosion engineering analysis - Coating integrity (handling) rationale - Biocompatibility risk assessment ## Conclusion The information included in this submission demonstrates that the ELEOS Limb Salvage System with NanoCept® Technology is substantially equivalent to the legally marketed predicate devices, ELEOSx™ Limb Salvage System (DEN210058) and ELEOS™ Limb Salvage System (K161520). --- **Source:** [https://fda.innolitics.com/submissions/OR/de-novo-classifications/QZZ/K252920](https://fda.innolitics.com/submissions/OR/de-novo-classifications/QZZ/K252920) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com