# K143366: ADVANCE Porous Coated Spiked Tibial Base

- Pathway: 510(k) (Special)
- Applicant: Microport Orthopedics, Inc.
- Decided: Jan 21, 2015 after 58 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: 1 generation back to K043083 (2005). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043083: Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel, Wrightmedicaltechnologyinc (2005) Summary page 4.

## Most influential descendants
- K152298: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base (2015), 8 descendants of its own
- 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 (2017), 7 descendants of its own
- K171389: EVOLUTION Revision CCK System (2017), 3 descendants of its own
- 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® Porous Coated Spiked Tibial Base is 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® Porous Coated Spiked Tibial Base is for uncemented use only.

Source page: https://510kreport.com/device/K143366
Methodology: https://510kreport.com/methodology