Eleos Limb Salvage System
Eleos Segmental Stem, Canal Filling, Bowed, Slotted, Splined, 2/3 Plasma, 36MM Collar, 18MM X 152MM
13manufacturers in China registered for this device type
35catalogue numbers in this listing
3510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Onkos Surgical, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161520 |
| Record published | 2022-03-11 |
| Record revised | 2022-05-25 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FB-18152-03M | In distribution | |
| FB-17152-03M | In distribution | |
| CS-09100-03M | In distribution | |
| CB-13152-03M | In distribution | |
| CB-11152-03M | In distribution | |
| FS-18120-03M | In distribution | |
| CS-17120-03M | In distribution | |
| FS-21120-03M | In distribution | |
| FB-11152-03M | In distribution | |
| FS-12120-03M | In distribution | |
| CS-15120-03M | In distribution | |
| FS-19120-03M | In distribution | |
| FS-17120-03M | In distribution | |
| CB-15152-03M | In distribution | |
| CB-11200-03M | In distribution | |
| CS-10100-03M | In distribution | |
| FS-13120-03M | In distribution | |
| FB-20152-03M | In distribution | |
| FB-12152-03M | In distribution | |
| CB-17152-03M | In distribution | |
| FB-21152-03M | In distribution | |
| FB-15152-03M | In distribution | |
| CS-11120-03M | In distribution | |
| FS-11120-03M | In distribution | |
| CS-13120-03M | In distribution | |
| FB-19152-03M | In distribution | |
| FB-16152-03M | In distribution | |
| FB-14152-03M | In distribution | |
| FS-20120-03M | In distribution | |
| FB-13152-03M | In distribution | |
| FS-15120-03M | In distribution | |
| CB-15200-03M | In distribution | |
| CB-13200-03M | In distribution | |
| FS-16120-03M | In distribution | |
| FS-14120-03M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203815 | 2021-06-09 |
| K203588 | 2021-02-05 |
| K203090 | 2020-12-11 |
Recalls Naming This Product
12 recalls name this product by its own identifiers, the UDI on its label or 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. | UDI-DI | 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 49 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
3 of these are 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 |
|---|---|---|---|---|
| 2023-12-22 | Class II | Labeling Change Control | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as s | 23 units |
| 2023-12-22 | Class II | Labeling Change Control | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as s | 23 units |
| 2023-09-01 | Class II | Packaging change control | Potential for breach of Tyvek seals. | 233 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.