# K162775: Legion Cone System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 13, 2017 after 102 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K850055 (1985). 33 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 4.
- K080625: Smith & Nephew Mis Hip Stem with Stiktite, Smith & Nephew, Inc. (2008) Summary page 5.
- K103256: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2011) Summary page 5.
- K123012: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2012) Summary page 5.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 5.

## Most influential descendants
- K180334: LEGION Knee System (2018), 4 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K261462: LANDMARK Total Knee System (2026), 0 descendants of its own
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own
- K242711: JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (2024), 0 descendants of its own

## Recalls of this device
- May 30, 2017 · Class II · Z-2625-2017: The incorrect Loctite adhesive was used to assemble the impactor heads.
- May 30, 2017 · Class II · Z-2624-2017: The incorrect Loctite adhesive was used to assemble the impactor heads.

## Indications for use
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, ot total knee replacement. 4, Postetior stabilized knee systers 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 infact. 5. 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) ate incompetent. 6. Hinge 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 of incompetent. These are single use implants and are intended for use with and without bone cement.

Source page: https://510kreport.com/device/K162775
Methodology: https://510kreport.com/methodology