510(k) · Cleared
Recalled · Class II · 2023ELEOS Limb Salvage System with BioGrip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onkos Surgical · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 9, 2021 as substantially equivalent to K203090 (Onkos Surgical, 2020) and 1 other predicate after a 162-day review. Its family tree reaches back 3 generations to 1994. It has been recalled 3 times.
- Decided
- Jun 9, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932222 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK932222 SLT Femoral HeadDow Corning Wright · 1994
- 2 generations backK161520 ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · Recalled
- 1 generation backK203090 ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020
- This deviceK203815 ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932222 | SLT Femoral Head | Dow Corning Wright | 1994 | — |
| −2 | K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016 | 11 |
| −1 | K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020 | — |
| 0 (this device) | K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203090 | ELEOS Limb Salvage System featuring BIOGRIPSummary page 5…II Product Code(s): JDI KRO JWH LPH LZO KWY 5.3. Predicate and Reference Devices ELEOS™ Limb Salvage System with BioGrip™, Onkos Surgical, Inc., K203090 (Predicate Device) ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520 (Predicate Device) Modular Endoprosthetic Tumour Sys… | 2020 |
| * | K161520 | ELEOS Limb Salvage SystemSummary page 5…dicate and Reference Devices ELEOS™ Limb Salvage System with BioGrip™, Onkos Surgical, Inc., K203090 (Predicate Device) ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520 (Predicate Device) Modular Endoprosthetic Tumour System (METS), Stanmore, K121029 (Reference Device) Modular Endoprosthetic Tumou… | 2016 |
| † | K121029 | Mets Modular Distal Femur | 2012 |
| † | K121056 | Mets Modular Proximal Femur | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2023 | Class II | Z-1817-2025 | 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… |
| Dec 22, 2023 | Class II | Z-1818-2025 | 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… |
| Sep 1, 2023 | Class II | Z-1883-2025 | Packaging change control | Potential for breach of Tyvek seals. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ELEOS™ Limb Salvage System Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function 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…
Read the full statement (284 words)
ELEOS™ Limb Salvage System Hip Components:
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function 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.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions:
1) Patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
2) Surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
3) Metastatic diseases
ELEOS™ Limb Salvage System with Knee Components:
Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2) Inflammatory degenerative joint disease including 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.
Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:
1) Patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
2) Surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.
3) Metastatic diseases
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203815: ELEOS Limb Salvage System with BioGrip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203815
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026