# K013035: Guardian Limb Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 7, 2001 after 88 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lacey Rotating Hinge Knee: named in the summary without a submission number
- (no number) DCW Modular Distal Femoral System: named in the summary without a submission number
- (no number) S.O.S.™ Proximal Femur: named in the summary without a submission number

## Most influential descendants
- K161520: ELEOS Limb Salvage System (2016), 6 descendants of its own
- K230563: EVOLUTION® Hinge Knee System (2023), 1 descendant of its own
- K203090: ELEOS Limb Salvage System featuring BIOGRIP (2020), 1 descendant of its own
- K253066: ELEOS™ with NanoCept® Technology Limb Salvage System (2026), 0 descendants of its own
- K252920: ELEOS™ Limb Salvage System with NanoCept® Technology (2025), 0 descendants of its own

## Recalls of this device
- Jan 3, 2006 · Not classified · Z-0523-06: The product was not fully assembled prior to packaging.
- Jul 14, 2004 · Not classified · Z-1405-04: Potential for self -locking axial pin to dislodge and 'back out'.

## Indications for use
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)

Source page: https://510kreport.com/device/K013035
Methodology: https://510kreport.com/methodology