# K972626: Advance Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 29, 1997 after 77 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.
34 later devices descend from it; 6 cite it directly.
0 of 35 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 Total Knee System: named in the summary without a submission number

## Most influential descendants
- K121416: GMK Sphere (2012), 20 descendants of its own
- K140826: GMK Sphere Extension (2014), 17 descendants of its own
- K162035: GMK Sphere (2017), 10 descendants of its own
- K113325: Evolution MP Adaptive CS Insert (2011), 7 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own

## Indications for use
The ADVANCE® Total Knee System components are 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 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. These products are for use with cement only.

Source page: https://510kreport.com/device/K972626
Methodology: https://510kreport.com/methodology