# K972770: Advance Ultra-Congruent Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 21, 1997 after 89 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 5 cite it directly.
0 of 31 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) Intermedics Natural Knee Ultra-Congruent Tibial Insert: 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

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1637-2010: The left medial pivot and right medial pivot inserts were co-mingled
- Nov 24, 2009 · Not classified · Z-1636-2010: The left medial pivot and right medial pivot inserts were co-mingled

## Indications for use
The ADVANCE® Ultra-Congruent Tibial Insert is 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 S) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement.

Source page: https://510kreport.com/device/K972770
Methodology: https://510kreport.com/methodology