# K122218: Advance Total Knee System-Patella

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 21, 2013 after 239 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894334 (1989). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953439: Ultrack Total Knee System, Wrightmedicaltechnologyinc (1996) Summary page 1.
- K061223: Advance Total Knee System, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K894334: Second Generation Knee System, Orthomet, Inc. (1989) Summary page 1.

## Most influential descendants
- K240043: EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (2024), 0 descendants of its own
- K152631: MPO Total Knee Systems MR Labeling (2016), 0 descendants of its own

## Indications for use
The ADVANCE' Total Knee System is indicated for use in knee arthroplasty 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 treatment of fractures that are unmanageable using other techniques. Porous-coated total knee replacement components are for use without bone cement.

Source page: https://510kreport.com/device/K122218
Methodology: https://510kreport.com/methodology