# K973524: Advance Modular Tibial Component

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 12, 1997 after 86 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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) AXIOM® Modular Tibial Component: named in the summary without a submission number
- (no number) ADVANCE® Cobalt Chrome Tibial Component: named in the summary without a submission number

## Most influential descendants
- K161520: ELEOS Limb Salvage System (2016), 6 descendants 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
- K211677: ELEOS Limb Salvage System (2021), 0 descendants of its own

## Recalls of this device
- Feb 19, 2010 · Not classified · Z-1215-2010: The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).

## Indications for use
Indicated for use in total 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 Jomt 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. For cemented use only.

Source page: https://510kreport.com/device/K973524
Methodology: https://510kreport.com/methodology