# K242412: Agility Symmetric™ Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Medisurge, LLC
- Decided: Nov 6, 2024 after 84 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: 11 generations back to K810258 (1981). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080199: Symmetric Total Knee System, Signal Medical Corporation (2008) Summary page 4.
- K141635: Arthrex Ibalance Tka System, Arthrex, Inc. (2014) Summary page 5.

## Indications for use
Indications: Indications for Total Knee Replacement: 1. Rheumatoid arthritis, 2. Correction of functional deformity, 3. Osteoarthritis, 4. Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result, 5. Failed osteotomies, unicompartmental replacement, or total knee replacement. The femoral component and tibial tray are for cemented use or uncemented use (biological fixation). The patellar component and metaphyseal stem (K080199) are for cemented use only. Indications for Posterior Stabilized Knee Replacement: Posterior stabilized knee system and systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply. Indications for Constrained Knee Replacement: Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

Source page: https://510kreport.com/device/K242412
Methodology: https://510kreport.com/methodology