# K033890: Advance Double High Insert

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 15, 2004 after 30 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 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 Insert: named in the summary without a submission number
- (no number) AXIOM® Standard Tibial Insert: named in the summary without a submission number

## Most influential descendants
- K102380: Evolution MP Total Knee System (2011), 11 descendants of its own
- K113325: Evolution MP Adaptive CS Insert (2011), 7 descendants of its own
- K131679: Evolution MP Adaptive PS Tibial Insert (2013), 6 descendants of its own
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts (2014), 5 descendants of its own
- K182251: EVOLUTION NitrX Medial-Pivot Knee (2019), 4 descendants of its own

## Indications for use
The ADVANCE® Double High Insert is 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. The ADVANCE® Double High Insert is for single cemented use.

Source page: https://510kreport.com/device/K033890
Methodology: https://510kreport.com/methodology