# K081479: Advance a-Class Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 20, 2009 after 269 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) ADVANCE® Medial Pivot Tibial Insert: named in the summary without a submission number
- (no number) LINEAGE® A-CLASS® Acetabular Liner: named in the summary without a submission number

## 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

## Indications for use
The ADVANCE A-CLASS Tibial Insert is indicated for use with the Advance Total Knee system 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. The ADVANCE A-CLASS Insert is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

Source page: https://510kreport.com/device/K081479
Methodology: https://510kreport.com/methodology