Eleos™ Limb Salvage System
ELEOS Limb Salvage System is a modular lower-limb reconstruction family with stems and joint-replacement components. Stem segments provide an anchoring part of assemblies used for proximal…
ELEOS Limb Salvage System is a modular lower-limb reconstruction family with stems and joint-replacement components. Stem segments provide an anchoring part of assemblies used for proximal or distal femur, total femur, proximal tibia or hinged-knee reconstruction.
The system combines stems and extensions with components such as mid-sections, femoral heads, hinge assemblies and tibial spacers. The selected combination determines the portion of the limb being reconstructed.
Listed Item
ELEOS Segmental Stem, Cemented, 11mm x 255mm, Bowed, Fluted, 32mm Collar
Modular Component Roles
A segmental stem is one part of the reconstruction, while a hinge, head or tibial bearing supplies a different joint-interface role. The range also includes sleeves, wedges and augments, with separate instruments supplied in nonsterile trays for reprocessing.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Onkos Surgical, Inc., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161520 |
| Record published | 2022-06-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Width 60 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB-11255-03M | In distribution | |
| TB-2204E-01M | Width 75 mm | In distribution |
| TB-TSCRW-01M | In distribution | |
| RF-TSCRW-01N | Style: Right | In distribution |
| THSMWOS01M | In distribution | |
| RF-L002E-01M | Width 60 mm | In distribution |
| TB-2202E-01M | Width 65 mm | In distribution |
| TB-2203E-01M | Width 70 mm | In distribution |
| TB-TSCRW-01N | Style: Right | In distribution |
| RF-L004E-01M | Width 70 mm | In distribution |
| RF-R004E-01M | Width 70 mm | In distribution |
| RF-R003E-01M | Width 65 mm | In distribution |
| TB-2205E-01M | Width 80 mm | In distribution |
| RF-L003E-01M | Width 65 mm | In distribution |
| RF-R002E-01M | Width 60 mm | In distribution |
| CB-17200-03M | In distribution | |
| RF-TSCRW-01M | In distribution | |
| TB-2201E-01M | Width 60 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211677 | 2021-07-28 |
| K161520 | 2016-10-28 |
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Onkos Surgical, Inc. | 510(k) number | 2025-07-11 | Class II | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 30 units | |
| Onkos Surgical, Inc. | 510(k) number | 2025-07-11 | Class II | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 15 units | |
| Onkos Surgical, Inc. | 510(k) number | 2025-07-11 | Class II | Under Investigation by firm | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. | 554 units | |
| Onkos Surgical, Inc. | 510(k) number | 2024-09-22 | Class II | Nonconforming Material/Component | Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. | 24 units | |
| Onkos Surgical, Inc. | 510(k) number | 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 147 units | |
| Onkos Surgical, Inc. | 510(k) number | 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 120 units | |
| Onkos Surgical, Inc. | 510(k) number | 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 77 units | |
| Onkos Surgical, Inc. | 510(k) number | 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 99 units | |
| Onkos Surgical, Inc. | 510(k) number | 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
| Onkos Surgical, Inc. | 510(k) number | 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
| Onkos Surgical, Inc. | 510(k) number | 2017-05-23 | Class II | Process control | The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm | 4 units | 2018-06-27 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 49 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.