# K121393: Smith & Nephew, Inc. Total Knee System Instrumentation - Pathway: 510(k) (Traditional) - Applicant: Smith & Nephew, Inc. - Decided: Aug 7, 2012 after 90 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: 4 (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). 41 ancestors in all. 5 later devices descend from it; 3 cite it directly. 0 of 47 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. - K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 2. - K954909: Profix Posterior-Stabilized Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 2. - K032683: Genesis II Porous Plus HA Knee System, 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. - K051229: Profix Flex Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 2. - K101499: Journey CR Knee System, Smith & Nephew, Inc. (2010) Summary page 2. - K962557: Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component, Smith & Nephew Richards, Inc. (1996) Summary page 2. - K032295: Genesis II Posterior Stabilized High Flexion Articular Insert, Smith & Nephew, Inc. (2003) Summary page 2. - K946236: Profix Conforming Plus Tibial Insert, Smith & Nephew Richards, Inc. (1995) Summary page 2. - K030623: Smith & Nephew Profix Total Knee System, Smith & Nephew, Inc. (2003) Summary page 2. - K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 2. - K100897: Legion Porous + HA Tibial Baseplates, Smith & Nephew, Inc. (2010) Summary page 2. - K073325: Legion Porous Primary, Smith & Nephew, Inc. (2007) - K962137: Genesis II Constrained System, Smith & Nephew Richards, Inc. (1996) Summary page 3. - K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 3. - K060742: Legion Cobalt Chrome Revision Knee System, Smith & Nephew, Inc. (2006) Summary page 3. - K072531: Legion Stem with Holes, Smith & Nephew, Inc. (2007) Summary page 3. - K963255: Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 3. - K041106: Revision Knee System, Smith & Nephew, Inc. (2004) Summary page 3. - K081111: Legion Hinge Knee System, Smith & Nephew, Inc. (2008) Summary page 3. ## Cited in the summary but kept off the family tree - K953120: Vital Signs Heparin Vascular Access Flush Device, Vital Signs, Inc. (1995). Our reading of the summary gave K953120, FDA’s number for Vital Signs Heparin Vascular Access Flush Device (Vital Signs, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS”. Kept off the family tree. - K070927: Hemosil D-Dimer HS, Instrumentation Laboratory CO (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K123159: Smith & Newphew, Inc. Disposable Knee Instruments (2013), 2 descendants of its own - K173331: JOURNEY II XR Knee Instruments (2017), 1 descendant of its own - K200227: Journey II XR Knee Instrument (2020), 0 descendants of its own - K143226: Visionaire Disposable Instruments (2015), 0 descendants of its own - K141585: Smith & Nephew Disposable Fin Punch (2014), 0 descendants of its own ## Recalls of this device - Dec 16, 2019 · Class II · Z-0878-2020: Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. - Sep 18, 2018 · Class II · Z-0200-2019: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. - May 4, 2018 · Class II · Z-2163-2018: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. - Apr 9, 2018 · Class II · Z-1902-2018: A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa. ## Indications for use Smith & Nephew Hinge Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hinge Total Knee Systems and their cleared Indications for Use. Indications for Hinged Total Knees 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. 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. Hinged Total Knee components are indicated for use with cement and are single use devices. Smith & Nephew Constrained Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Constrained Total Knee Systems and their cleared Indications for Use. Indications for Constrained Total Knees 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. Constrained Total Knee components are indicated for use with cement and are single use devices. Smith & Nephew Posterior Stabilized Cementless Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Posterior Stabilized Cementless Knee Systems and their cleared Indications for Use. Indications for Posterior Stabilized Cementless Knee Replacement 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices. Smith & Nephew Posterior Stabilized Cemented Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Posterior Stabilized Cemented Knee Systems and their cleared Indications for Use. Indications for Posterior Stabilized Cemented Knee Replacement 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices. Smith & Nephew Cruciate Retaining Cementless Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cruciate Retaining Cementless Knee Systems and their cleared Indications for Use. Indications for Cruciate Retaining Cementless Knee Replacement 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices. Smith & Nephew Cruciate Retaining Cemented Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cruciate Retaining Cemented Knee Systems and their cleared Indications for Use. Indications for Cruciate Retaining Cemented Knee Replacement 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices. Source page: https://510kreport.com/device/K121393 Methodology: https://510kreport.com/methodology