# 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 - Pathway: 510(k) (Traditional) - Applicant: Smith & Nephew, Inc. - Decided: May 4, 2023 after 56 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: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K810258 (1981). 211 ancestors in all. 3 later devices descend from it; 3 cite it directly. 0 of 214 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K142807: ANTHEM PS Total Knee System, Smith & Nephew, Inc. (2014) Summary page 24. - K170648: ANTHEM CR Total Knee System, Smith & Nephew, Inc. (2017) Summary page 24. - K030301: Unicondylar Femoral Component, Smith & Nephew, Inc. (2003) Summary page 24. - K912735: Genesis Unicompartmental Knee System, Smith & Nephew Richards, Inc. (1991) Summary page 24. - K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 24. - K111711: Journey II BCS Knee System, Smith & Nephew, Inc. (2011) Summary page 24. - K140555: Journey II BCS Constrained Inserts, Smith & Nephew, Inc. (2014) Summary page 24. - K113482: Journey II Deep Dished Articular Inserts, Smith & Nephew, Inc. (2012) Summary page 24. - K121443: Journey II CR Knee System, Smith & Nephew, Inc. (2012) Summary page 24. - K152315: JOURNEY II Uni Tibial Base and Insert, Smith & Nephew, Inc. (2015) Summary page 24. - K190085: Journey II Unicompartmental Knee System, Smith & Nephew, Inc. (2019) Summary page 8. - K152726: JOURNEY II XR Knee System, Smith & Nephew, Inc. (2015) Summary page 24. - K051086: Smith & Nephew Patello-Femoral Implant, Smith & Nephew, Inc. (2005) Summary page 24. - K061011: Competitor Unicondylar Knee Tibial Baseplate, Smith & Nephew, Inc. (2006) Summary page 24. - K061779: Competitor Unicondylar All-Poly Tibial Baseplate, Smith & Nephew, Inc. (2006) Summary page 24. - K073175: Journey Unicondylar Femoral Implant, Smith & Nephew, Inc. (2007) Summary page 24. - K102069: Journey Unicondylar Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 24. - K151118: Smith and Nephew Legion Hinge Knee System, Smith & Nephew (2015) Summary page 24. - K081111: Legion Hinge Knee System, Smith & Nephew, Inc. (2008) Summary page 24. - K041106: Revision Knee System, Smith & Nephew, Inc. (2004) Summary page 25. - K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 25. - K060742: Legion Cobalt Chrome Revision Knee System, Smith & Nephew, Inc. (2006) Summary page 25. - K071071: Crosslinked Polyethylene Articular Inserts, Smith & Nephew, Inc. (2007) Summary page 25. - K072531: Legion Stem with Holes, Smith & Nephew, Inc. (2007) Summary page 25. - K073325: Legion Porous Primary, Smith & Nephew, Inc. (2007) Summary page 25. - K091543: Legion Porous Plus HA Primary Femoral Components, Smith & Nephew, Inc. (2009) Summary page 25. - K100897: Legion Porous + HA Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 25. - K112941: Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral Components, Smith & Nephew, Inc. (2011) Summary page 25. - K162775: Legion Cone System, Smith & Nephew, Inc. (2017) Summary page 25. - K180334: LEGION Knee System, Smith & Nephew, Inc. (2018) Summary page 25. - K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 25. - K122529: Zimmer Unicompartmental Knee System Vivacit-E Articular Surface, Zimmer, Inc. (2012) Summary page 25. - K190439: Engage™ Partial Knee System, Engage Uni, LLC (2019) Summary page 25. - K211221: Porous Patella and Porous Tibia Baseplate, Smith & Nephew, Inc. (2021) Summary page 25. ## Most influential descendants - 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 - Aug 31, 2023 · Class II · Z-2621-2023: The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the pr ## Indications for use 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. I. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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 II BCS Knee components are indicated for use only with cement and are single use devices. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. The Journey II Total Knee system components are indicated for use only with cement and are single use devices. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: I. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: • Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; • Correction of functional deformity; • Revision procedures where other treatments or devices have failed; and • Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. The Journey II Total Knee system components are indicated for use only with cement and are single use devices. 1. Degenerative arthritis in the distal femur and patella; 2. A history of patellar dislocation or patellar fracture; and 3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists. The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement. Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: l. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. 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) are 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 or incompetent. The Legion Hinge Knee System is for Cemented Use Only. 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. 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) are 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 or incompetent. The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement. These devices are indicated for patients with: 1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. 2. Previous tibial condyle or plateu fractures with loss of anatomy or function. 3. Varus or Valgus deformities. 4. Revision of previous arthroplasty procedures. The devices are indicated for cemented use only. The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. - Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty - As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis. The femoral component and tibial tray are intended for cementless or cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used. 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/K230653 Methodology: https://510kreport.com/methodology