# K092201: Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 20, 2009 after 29 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Sep 5, 2012 · Class II · Z-0183-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0184-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0185-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

## Indications for use
The ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are indicated for 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. ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.

Source page: https://510kreport.com/device/K092201
Methodology: https://510kreport.com/methodology