# K111711: Journey II BCS Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 16, 2011 after 88 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951987 (1995). 12 ancestors in all.
40 later devices descend from it; 7 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 1.
- K073325: Legion Porous Primary, Smith & Nephew, Inc. (2007) Summary page 2.
- K071071: Crosslinked Polyethylene Articular Inserts, Smith & Nephew, Inc. (2007) Summary page 2.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K032295: Genesis II Posterior Stabilized High Flexion Articular Insert, Smith & Nephew, Inc. (2003) Summary page 2.
- K091014: Journey BCS Knee System, Smith & Nephew, Inc. (2009) Summary page 2.

## Most influential descendants
- K121443: Journey II CR Knee System (2012), 37 descendants of its own
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K141471: Journey II XR Knee System (2014), 12 descendants of its own
- K190911: Physica KR Liner and SMR Reverse Humeral Liner (2019), 8 descendants of its own
- K152315: JOURNEY II Uni Tibial Base and Insert (2015), 8 descendants of its own

## Recalls of this device
- Sep 27, 2023 · Class II · Z-0158-2024: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, 
- Sep 27, 2023 · Class II · Z-0157-2024: The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, 
- Apr 19, 2022 · Class II · Z-1099-2022: It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems 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. Smith & Nephew, Inc. Journey 11BOS Knee components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K111711
Methodology: https://510kreport.com/methodology