510(k) · Cleared
ClearedELEOS Limb Salvage System featuring 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 Dec 11, 2020 as substantially equivalent to K161520 (Onkos Surgical, Inc., 2016) after a 59-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Dec 11, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932222 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK932222 SLT Femoral HeadDow Corning Wright · 1994
- 1 generation backK161520 ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · Recalled
- This deviceK203090 ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020
- Descendant · cites it directly · 0 of its ownK203815 ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K203815ELEOS Limb Salvage System with BioGripOnkos Surgical · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932222 | SLT Femoral Head | Dow Corning Wright | 1994 | — |
| −1 | K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016 | 11 |
| 0 (this device) | K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020 | — |
| +1 | K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K161520 | ELEOS Limb Salvage SystemSummary page 5…ncemented Regulatory Class: II Product Code(s): JDI KRO JWH LPH LZO 5.3. Predicate Device ELEOS™ Limb Salvage System, Onkos Surgical, Inc., K161520 5.4. Device Description The Onkos Surgical ELEOS™ Limb Salvage System consists of components that are used in the reconstructi… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203815 | ELEOS Limb Salvage System with BioGrip | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 22.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K203815 (Onkos Surgical, 2021) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K161520.
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. 2020, 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 with 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 (285 words)
ELEOS™ Limb Salvage System with 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/K203090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203090: ELEOS Limb Salvage System featuring BIOGRIP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203090
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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