510(k) · Cleared
Recalled · 2006Guardian Limb Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Dec 7, 2001 after an 88-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 7, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK013035 Guardian Limb Salvage SystemWrightmedicaltechnologyinc · 2001
- Descendant · cites it directly · 6 of its ownK161520 ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK230563 EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK203090 ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020
- Descendant · 2 generations on · 0 of its ownK253066 ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252920 ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · cites it directly6descendants
- K230563EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc. · 2023 · cites it directly1descendant
- K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020 · 2 generations on1descendant
- K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026 · 2 generations on0descendants
- K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013035 | Guardian Limb Salvage System | Wrightmedicaltechnologyinc | 2001 | — |
| +1 | K161520 | ELEOS Limb Salvage System | Onkos Surgical, Inc. | 2016 | 11 |
| +1 | K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | 2023 | — |
| +2 | K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020 | — |
| +2 | K253066 | ELEOS™ with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. | 2026 | — |
| +2 | K252920 | ELEOS™ Limb Salvage System with NanoCept® Technology | Onkos Surgical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 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? (3)
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 |
|---|---|---|---|
| * | — | Lacey Rotating Hinge Knee Named without a submission number | |
| * | — | DCW Modular Distal Femoral System Named without a submission number | |
| * | — | S.O.S.™ Proximal Femur Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2006 | Not classified | Z-0523-06 | Other | The product was not fully assembled prior to packaging. |
| Jul 14, 2004 | Not classified | Z-1405-04 | Other | Potential for self -locking axial pin to dislodge and 'back out'. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161520 (Onkos Surgical, Inc., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
GUARDIANT™ Limb Salvage 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, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional…
Read the full statement (298 words)
GUARDIANT™ Limb Salvage 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, protrusio 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) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)
The GUARDIAN™ Limb Salvage 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) noninflammatory 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) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)
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/K013035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013035: Guardian Limb Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013035
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026