# K211221: Porous Patella and Porous Tibia Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 1, 2021 after 161 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: 6 generations back to K933785 (1995). 33 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 4.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 4.
- K100897: Legion Porous + HA Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 4.
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 4.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 4.

## Most influential descendants
- 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
- K254084: AETOS Shoulder System - CONCELOC Glenoids (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

## Indications for use
Total knee components are indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. The posterior-stabilized knee system is 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. LEGION Porous CRNarrow Femoral Components are indicated for use without bone cement and are single use devices. The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K211221
Methodology: https://510kreport.com/methodology