510(k) · Cleared
ClearedELEOS™ with NanoCept® Technology Limb Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onkos Surgical, Inc. · QZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction
Cleared on Jun 8, 2026 as substantially equivalent to DEN210058 (Onkos Surgical, 2024) and 1 other predicate after a 259-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 8, 2026
- Review
- 259 days
- Class
- Class II
- Product code
- QZZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932222 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
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) | K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2024 | 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 QZZ? 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 QZZ device
- #1 K252920 ELEOS™ Limb Salvage System with NanoCept®…score 10.5 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | DEN210058 | ELEOSx™ Limb Salvage SystemSummary page 6…II Product Codes: QZZ, KRO, JDI, JWH, LPH, LZO Primary Predicate: ELEOS™ with NanoCept® Technology Limb Salvage System (DEN210058) Additional Predicates: ELEOS Limb Salvage System (K161520) Reference Device: Mariner Pedicle Screw System (DEN220015… | 2024 |
| * | K161520 | ELEOS Limb Salvage SystemSummary page 6…Primary Predicate: ELEOS™ with NanoCept® Technology Limb Salvage System (DEN210058) Additional Predicates: ELEOS Limb Salvage System (K161520) Reference Device: Mariner Pedicle Screw System (DEN220015)… | 2016 |
| † | DEN220015 | Orthobond Mariner Pedicle Screw System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 2 companies; a new generation was cleared every 22.4 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate DEN210058.
How does its category compare?
All QZZ devicesQZZ Limb And Joint Salvage Device With Coating For Bacteria Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QZZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZZ
Too few QZZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QZZ
No recall names QZZ since 2007.
Adverse event reports per year · QZZ
30in 2025
MAUDE reports naming product code QZZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 30 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ELEOS™ and ELEOS™ with NanoCept® Technology 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, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; 2.…
Read the full statement (254 words)
The ELEOS™ and ELEOS™ with NanoCept® Technology 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, 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™ and ELEOS™ with NanoCept® Technology Limb Salvage System is also indicated for procedures where resection and replacement of the proximal femur, intercalary portion of the femur, total 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
The ELEOS™ with NanoCept® Technology MDPB coating, where applied, is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device components. The clinical impact associated with the MDPB coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The MDPB coating is not intended to treat existing infections and does not act within or on the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253066: ELEOS™ with NanoCept® Technology Limb Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253066
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026