# K071071: Crosslinked Polyethylene Articular Inserts

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 19, 2007 after 156 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951987 (1995). 9 ancestors in all.
66 later devices descend from it; 5 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 2.
- K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) Summary page 2.
- K032295: Genesis II Posterior Stabilized High Flexion Articular Insert, Smith & Nephew, Inc. (2003) Summary page 2.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 2.
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K111711: Journey II BCS Knee System (2011), 40 descendants of its own
- K121443: Journey II CR Knee System (2012), 37 descendants of its own
- K093746: Verilast Wear Claims for the Legion Primary Knee System (2010), 29 descendants of its own
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K142787: Zimmer Persona Personalized Knee System (2014), 16 descendants of its own

## Recalls of this device
- Dec 19, 2019 · Class II · Z-1507-2020: LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
- Mar 30, 2018 · Class II · Z-1907-2018: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- Mar 30, 2018 · Class II · Z-1905-2018: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- Mar 30, 2018 · Class II · Z-1906-2018: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- Mar 30, 2018 · Class II · Z-1904-2018: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

## Indications for use
Total Knee components are indicated for rheumatoid arthritis: post-traumatic arthritis, osleoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact, Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent or inadequate. Smith & Nephew, Inc. Crosslinked Polyethylene Articular Inserts are single use devices. The indications for each device system are identical to the indications for each cleared predicate knee system

Source page: https://510kreport.com/device/K071071
Methodology: https://510kreport.com/methodology