# K061223: Advance Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 18, 2006 after 108 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 13 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
1 of 11 devices in its family (counting itself) has 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: named in the summary without a submission number

## Most influential descendants
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts (2014), 5 descendants of its own
- K122218: Advance Total Knee System-Patella (2013), 2 descendants of its own
- K093405: Prophecy Pre-Operative Navigation Alignment Guides (2010), 2 descendants of its own
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own
- K103598: Prophecy Pre-Operative Navigation Alignment Guides (2011), 1 descendant of its own

## Recalls of this device
- Jun 21, 2016 · Class I · Z-2701-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2696-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2703-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2698-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2702-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2695-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2697-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2694-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2699-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2693-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Jun 21, 2016 · Class I · Z-2700-2016: ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Sep 22, 2009 · Not classified · Z-0493-2010: Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absen
- Sep 22, 2009 · Not classified · Z-0492-2010: Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absen

## Indications for use
The ADVANCE® Total Knee System 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® Total Knee System components are for use without bone cement and are single use devices.

Source page: https://510kreport.com/device/K061223
Methodology: https://510kreport.com/methodology