# K974328: Advance Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 30, 1998 after 73 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.
65 later devices descend from it; 2 cite it directly.
0 of 66 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® Total Knee System All Polyethylene Tibial Components: named in the summary without a submission number

## Most influential descendants
- K052687: Conformis, Inc. Total Knee Repair System (2006), 43 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K103117: Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 40 descendants of its own
- K112780: Conformis Itotal Cruciate Retaining (CR) Knee Replacement System (2011), 38 descendants of its own
- K120316: Itotal Cruciate Retaining (CR) Knee Replacement System (2012), 36 descendants of its own

## Indications for use
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. This device is intended for use with bone cement.

Source page: https://510kreport.com/device/K974328
Methodology: https://510kreport.com/methodology