ELEOS Limb Salvage System

{0}------------------------------------------------ July 28, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Onkos Surgical Matthew (Matt) Vernak Vice President, Quality and Regulatory 77 East Halsey Rd Parsippany, New Jersey 07054 # Re: K211677 Trade/Device Name: ELEOS™ Limb Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, JDI, JWH, LPH, LZO Dated: June 1, 2021 Received: June 1, 2021 Dear Matthew (Matt) Vernak: 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. 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Sincerely, Ting Song, PhD 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211677 Device Name ELEOSTM Limb Salvage System ### Indications for Use (Describe) The ELEOS™ Limb Salvage System 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, 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 Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the 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 | Type of Use (Select one or both, as applicable) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | <table border="0"><tr><td><div> <span> <b> </b> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td></tr><tr><td><div> <span> <b> </b> <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <b> </b> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | <div> <span> <b> </b> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | | | <div> <span> <b> </b> <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054 Phone: (551) 579-1081 Contact Person: Matthew Vernak Email: mvernak@onkossurgical.com Date Prepared: 28-Jul-2021 5.2. Device | Name of Device: | ELEOS™ Limb Salvage System | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Limb Salvage System | | Classification Name: | 21 CFR 888.3510, Prosthesis, Knee, Femorotibial, Constrained,<br>Metal Polymer, Cemented<br>21 CFR 888.3350, Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Cemented<br>21 CFR 888.3560, Knee joint patellofemorotibial<br>polymer/metal/polymer semi- constrained cemented prosthesis<br>21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained,<br>Metal/Polymer, Porous, Uncemented<br>21 CFR 888.3353, Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer Cemented or Non-Porous, Uncemented | | Regulatory Class: | II | | Product Code(s): | KRO JDLJWH LPH LZO | - Predicate Device 5.3. ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520 (Primary Predicate) Orthogenesis LPS System, DePuy, Inc., K003182 (Predicate) #### ર્ડ 4. Device Description The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction are proximal femur, intercalary portion of the femur, distal femur, total femur, proximal tibia, and hinged knee. The ELEOS Limb Salvage components are femoral head, proximal femur, female stem, mid-section, segmental stem, distal femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial baseplate, male-male mid {4}------------------------------------------------ section, resurfacing femur, proximal tibia, patella, stem extension, and tibial wedges and augments. Instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions. | | RECONSTRUCTION APPLICATIONS | | | | | | |------------------------|-----------------------------|-------------|-----------------|----------------|-------------------|----------------| | Components | Proximal<br>Femur | Intercalary | Distal<br>Femur | Total<br>Femur | Proximal<br>Tibia | Hinged<br>Knee | | Femoral head | ✓ | | | ✓ | | | | Proximal Femur | ✓ | | | ✓ | | | | Female Stem | | ✓ | | | | | | Mid-Section | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | Segmental Stem | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | | Distal Femur | | | ✓ | ✓ | | | | Tibial Hinge Component | | | ✓ | ✓ | ✓ | ✓ | | Axial Pin | | | ✓ | ✓ | ✓ | ✓ | | Tibial Poly Spacer | | | ✓ | ✓ | ✓ | ✓ | | Tibial Baseplate | | | ✓ | ✓ | ✓ | ✓ | | Male-Male Midsection | | | | ✓ | | | | Resurfacing Femur | | | | | ✓ | ✓ | | Proximal Tibia | | | | | ✓ | ✓ | | Patella1 | | | ✓ | ✓ | ✓ | ✓ | | Wedges and Augments1 | | | ✓ | ✓ | ✓ | ✓ | | Stem Extensions1 | | | ✓ | ✓ | ✓ | ✓ | 1 – These implants are optional for each procedure. The surgeon shall use their medical judgement to determine if these implants are necessary based on factor such as patient bone quality, joint stability, and pathology. The implants are single use devices. {5}------------------------------------------------ #### 5.5. Indications for Use The ELEOS™ Limb Salvage System is indicated for resection and replacement of the proximal femur, intercalary portion of the femur, total 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 Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the 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 #### Comparison of Technological Characteristics with the Predicate Device 5.6. The subject device incorporates a new indication for use, intercalary replacement. This is in addition to the current indications of the primary predicate ELEOS Limb Salvage System and consistent with the indications of the predicate DePuy LPS System. The subject device is a line extension to the primary predicate device and can be used interchangeably with existing system components. The design of the female stem will utilize the same material, segmental taper, cement flutes, and length as the primary predicate, ELEOS Limb Salvage System. #### 5.7. Performance Data A risk-based evaluation of the subject and predicate device determined that the addition of the female stem to complete an intercalary replacement does not raise new concerns with respect to safety and/or effectiveness of the device. This is demonstrated by no new or increased risks related to loosening, subsidence, fatigue, dissociation, and/or fretting corrosion compared to the primary predicate device. Therefore, additional performance testing was not required to support this submission. #### 5.8 Clinical Data Clinical data was not deemed necessary for the subject device. {6}------------------------------------------------ #### Conclusions 5.9 Based on the test results and supporting documentation provided in this premarket notification, the subject ELEOS Limb Salvage System is substantially equivalent to the primary predicate, ELEOS Limb Salvage System, and predicate, Orthogenesis LPS System. The content in this premarket notification demonstrates that: - . any differences do not raise new questions of safety and effectiveness; - and the proposed device is at least as safe and effective as the legally marketed predicate ● devices.