# K152631: MPO Total Knee Systems MR Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Mar 23, 2016 after 190 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K033890 (2004). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142550: EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments, Microport Orthopedics, Inc. (2014) Summary page 4.
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts, Microport Orthopedics, Inc. (2014) Summary page 4.
- K131679: Evolution MP Adaptive PS Tibial Insert, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K122218: Advance Total Knee System-Patella, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K113325: Evolution MP Adaptive CS Insert, Wrightmedicaltechnologyinc (2011) Summary page 5.
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 5.
- K063731: Advance Stature Femoral Component, Wrightmedicaltechnologyinc (2007) Summary page 5.
- K063128: Advance Spiked Porous Tibial Base, Wrightmedicaltechnologyinc (2007) Summary page 5.
- K061223: Advance Total Knee System, Wrightmedicaltechnologyinc (2006) Summary page 5.
- K043083: Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel, Wrightmedicaltechnologyinc (2005) Summary page 5.
- K033890: Advance Double High Insert, Wrightmedicaltechnologyinc (2004) Summary page 5.
- K990030: Advanced Revision Product Line Extension, Wrightmedicaltechnologyinc (1999) Summary page 5.
- K973524: Advance Modular Tibial Component, Wrightmedicaltechnologyinc (1997) Summary page 5.
- K972626: Advance Knee System, Wrightmedicaltechnologyinc (1997) Summary page 5.
- K960617: Advance Tibial Component, Wrightmedicaltechnologyinc (1996) Summary page 5.
- K953439: Ultrack Total Knee System, Wrightmedicaltechnologyinc (1996) Summary page 5.
- K932858: Ortholoc Advantim Tibial Base Component, Dow Corning Wright (1994) Summary page 5.
- K930228: Ortholoc Advantim Tibial Stem 5 Degree, Dow Corning Wright (1993) Summary page 5.
- K894334: Second Generation Knee System, Orthomet, Inc. (1989) Summary page 5.

## Indications for use
MPO Total Knee Systems are indicated for use in knee arthroplasty 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 treatment of fractures that are unmanageable using other techniques. ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement. Porous-Coated Total Knee Replacement Components are for use without bone cement. The EVOLUTION® Total Knee System is for cemented use only.

Source page: https://510kreport.com/device/K152631
Methodology: https://510kreport.com/methodology