# K170288: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Jun 15, 2017 after 136 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: 2 generations back to K082924 (2009). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063128: Advance Spiked Porous Tibial Base, Wrightmedicaltechnologyinc (2007) Summary page 4.
- K122382: Dynasty Biofoam Shell, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Most influential descendants
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own
- K253728: EVOLUTION® AM BIOFOAM® Tibial System (2026), 0 descendants of its own

## Indications for use
The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory 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. The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only. The DYNASTY® BIOFOAM® Acetabular Shell is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed. The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

Source page: https://510kreport.com/device/K170288
Methodology: https://510kreport.com/methodology