# K161414: Anatomic Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Amplitude
- Decided: Jan 19, 2017 after 241 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K936079 (1994). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 4.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K071991: Modification to Scorpio NRG Knee System, Howmedica Osteonics Corp. (2007) Summary page 4.
- K082019: Freedom Total Knee System, Maxx Orthopedics, Inc. (2009) Summary page 4.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 4.

## Most influential descendants
- K230078: TRAX® CR Total Knee System (2023), 0 descendants of its own

## Indications for use
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; - Post-traumatic loss of knee joint configuration and function; - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Revision of previous unsuccessful knee replacement or other procedure. The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.

Source page: https://510kreport.com/device/K161414
Methodology: https://510kreport.com/methodology