# K213817: MPO Knee Instruments; MPO PROPHECY Knee Instruments

- Pathway: 510(k) (Special)
- Applicant: Microport Orthopedics, Inc.
- Decided: Jan 5, 2022 after 29 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: 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)
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts, Microport Orthopedics, Inc. (2014) Summary page 5.
- K142550: EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments, Microport Orthopedics, Inc. (2014) Summary page 5.
- K143366: ADVANCE Porous Coated Spiked Tibial Base, Microport Orthopedics, Inc. (2015) Summary page 5.
- K152298: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base, Microport Orthopedics, Inc. (2015) Summary page 5.
- K162026: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions, Microport Orthopedics, Inc. (2017) Summary page 5.
- K171389: EVOLUTION Revision CCK System, Microport Orthopedics, Inc. (2017) Summary page 5.
- K182125: EVOLUTION Stemmed CS Femur, Microport Orthopedics, Inc. (2018) Summary page 5.
- K093405: Prophecy Pre-Operative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2010) Summary page 5.
- K103598: Prophecy Pre-Operative Navigation Alignment Guides, Wrightmedicaltechnologyinc (2011) Summary page 5.

## Indications for use
MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below: MicroPort 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. Non-porous MicroPort total knee replacement implants are for cemented use only. Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM@ Tibial System and EVOLUTION® BIOFOAM@ Tibial System implants, are for use without bone cement. MicroPort's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

Source page: https://510kreport.com/device/K213817
Methodology: https://510kreport.com/methodology