510(k) · Cleared
Recalled · Class II · 2019Smith & Nephew, Inc. Total Knee System Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 7, 2012 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 21 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 7, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 4
- Predicates
- 24
Its longest line of descent runs back 5 generations to K951987 (1995). 41 ancestors in all, the oldest K853730 (1986). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
- 4 generations backK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
- 3 generations backK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
- 1 generation backK051229 Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005
- This deviceK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK173331 JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK200227 Journey II XR Knee InstrumentSmith & Nephew, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK143226 Visionaire Disposable InstrumentsSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK141585 Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013 · cites it directly2descendants
- K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · cites it directly1descendant
- K200227Journey II XR Knee InstrumentSmith & Nephew, Inc. · 2020 · 2 generations on0descendants
- K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc. · 2015 · 2 generations on0descendants
- K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951987 | Genesis II Total Knee System | Smith & Nephew Richards, Inc. | 1995 | 6 |
| −4 | K030612 | Genesis II Total Knee System | Smith & Nephew, Inc. | 2003 | — |
| −3 | K032295 | Genesis II Posterior Stabilized High Flexion Articular Insert | Smith & Nephew, Inc. | 2003 | 6 |
| −2 | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| −1 | K051229 | Profix Flex Cruciate Retaining Articular Insert | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | — |
| +1 | K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | Smith & Nephew, Inc. | 2013 | — |
| +1 | K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | 2017 | 4 |
| +2 | K200227 | Journey II XR Knee Instrument | Smith & Nephew, Inc. | 2020 | — |
| +2 | K143226 | Visionaire Disposable Instruments | Smith & Nephew, Inc. | 2015 | — |
| +1 | K141585 | Smith & Nephew Disposable Fin Punch | Smith & Nephew, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (24)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951987 | Genesis II Total Knee SystemSummary page 2…ms_______ ________ Description 510(k) Clearance Date GENESIS 11TOTAL KNEE SYSTEM K951987 8/22/1995 GENESIS POROUS TIBIAL TRAYS & REVISION K953274 '2/5/1996 KNEE SYSTEM PROFIX PO… | 1995 |
| * | K953274 | Genesis Porous Tibial Trays & Revision Knee SystemSummary page 2…510(k) Clearance Date GENESIS 11TOTAL KNEE SYSTEM K951987 8/22/1995 GENESIS POROUS TIBIAL TRAYS & REVISION K953274 '2/5/1996 KNEE SYSTEM PROFIX POSTERIOR STABILIZED KNEE SYSTEM K954909 1/31/1996 GENESIS… | 1996 |
| * | K954909 | Profix Posterior-Stabilized Knee SystemSummary page 2…8/22/1995 GENESIS POROUS TIBIAL TRAYS & REVISION K953274 '2/5/1996 KNEE SYSTEM PROFIX POSTERIOR STABILIZED KNEE SYSTEM K954909 1/31/1996 GENESIS 11POROUS PLUS HA KNEE SYSTEM K032683 10/15/2003 GENESIS 11DEEP FLEXION… | 1996 |
| * | K032683 | Genesis II Porous Plus HA Knee SystemSummary page 2…'2/5/1996 KNEE SYSTEM PROFIX POSTERIOR STABILIZED KNEE SYSTEM K954909 1/31/1996 GENESIS 11POROUS PLUS HA KNEE SYSTEM K032683 10/15/2003 GENESIS 11DEEP FLEXION CRUCIATE RETAINING K041825 3/11/2005 ARTICULAR INSERT HI… | 2003 |
| * | K041825 | Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSummary page 2…K954909 1/31/1996 GENESIS 11POROUS PLUS HA KNEE SYSTEM K032683 10/15/2003 GENESIS 11DEEP FLEXION CRUCIATE RETAINING K041825 3/11/2005 ARTICULAR INSERT HIGH PERFORMANCE KNEE K042515 3/14/2005 PR… | 2005 |
| * | K042515 | Smith & Nephew, Inc. High Performance KneeSummary page 2…0/15/2003 GENESIS 11DEEP FLEXION CRUCIATE RETAINING K041825 3/11/2005 ARTICULAR INSERT HIGH PERFORMANCE KNEE K042515 3/14/2005 PROFIX FLEX CRUCIATE RETAINING ARTICULAR K(051229 7/20/2005 INSERT JOURNEY CR K… | 2005 |
| * | K051229 | Profix Flex Cruciate Retaining Articular InsertSummary page 2…32+5 12/20/2007 LEGION POROUS PLUS HA PRIMARY FEMORAL K9531/120 COMPONENTS109531//29 PROFIX FLEX CRUCIATE RETAINING ARTICULAR K051229 7/20/2005 INSERT I GENESIS 11POSTERIOR STABILIZED HIGH FLEXION K032295 8/21/2003 INSE… | 2005 |
| * | K101499 | Journey CR Knee SystemSummary page 2…3/14/2005 PROFIX FLEX CRUCIATE RETAINING ARTICULAR K(051229 7/20/2005 INSERT JOURNEY CR KNEE SYSTEM K(101499 8/26/2010 GENESIS 11ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL K(962557 12/5/1… | 2010 |
| * | K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentSummary page 2…JOURNEY CR KNEE SYSTEM K(101499 8/26/2010 GENESIS 11ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL K(962557 12/5/1996 COMPONENT GENESIS 11POSTERIOR STABILIZED HIGH FLEXION K(032295 8/21/2003 INSERT.I… | 1996 |
| * | K032295 | Genesis II Posterior Stabilized High Flexion Articular InsertSummary page 2…S109531//29 PROFIX FLEX CRUCIATE RETAINING ARTICULAR K051229 7/20/2005 INSERT I GENESIS 11POSTERIOR STABILIZED HIGH FLEXION K032295 8/21/2003 INSERT GENESIS 11DEEP FLEXION CRUCIATE RETAINING K041825 3/11/2005 ARTICULAR IN… | 2003 |
| * | K946236 | Profix Conforming Plus Tibial InsertSummary page 2…6 COMPONENT GENESIS 11POSTERIOR STABILIZED HIGH FLEXION K(032295 8/21/2003 INSERT.I PROFIX CONFOMRING PLUS TIBIAL INSERT K(946236 7/6A1995 Smith & Nephew Inc. Cementless Total Knee Systems ________ Description… | 1995 |
| * | K030623 | Smith & Nephew Profix Total Knee SystemSummary page 2…510(k) -Clearance Date GENESIS 11POROUS PLUS HA KNEE SYSTEM K(032683 10/15/2003 * PROFIX TOTAL KNEE SYSTEM K(030623 5/22/2003 GENESIS 11TOTAL KNEE SYSTEM K(030612 5/27/2003 LEGION POROUS + HA TIBIAL BAS… | 2003 |
| * | K030612 | Genesis II Total Knee SystemSummary page 2…K(032683 10/15/2003 * PROFIX TOTAL KNEE SYSTEM K(030623 5/22/2003 GENESIS 11TOTAL KNEE SYSTEM K(030612 5/27/2003 LEGION POROUS + HA TIBIAL BASEPLATES K100897 5/13/2010 LEGION POROUS PRIMARY… | 2003 |
| * | K100897 | Legion Porous + HA Tibial BaseplatesSummary page 2…K(030623 5/22/2003 GENESIS 11TOTAL KNEE SYSTEM K(030612 5/27/2003 LEGION POROUS + HA TIBIAL BASEPLATES K100897 5/13/2010 LEGION POROUS PRIMARY K07332+5 12/20/2007 LEGION POROUS PLUS HA PRI… | 2010 |
| * | K073325 | Legion Porous Primary | 2007 |
| Kept off the family tree | K953120 | FDA’s K953120 is Vital Signs Heparin Vascular Access Flush Device 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. | 1995 |
| * | K962137 | Genesis II Constrained SystemSummary page 3…l Knee Systems Description 510(k) -Clearance bate GENESIS 11CONSTRAINED KNEE SYSTEM K962137 8/2/1996 REVISION KNEE SYSTEM K(043440 2/18/… | 1996 |
| * | K043440 | Smith & Nephew, Inc. Revision Knee SystemSummary page 3…e bate GENESIS 11CONSTRAINED KNEE SYSTEM K962137 8/2/1996 REVISION KNEE SYSTEM K(043440 2/18/2005 LEGION COBALT CHROME REVISION KNEE K(060742 5/3/'… | 2005 |
| * | K060742 | Legion Cobalt Chrome Revision Knee SystemSummary page 3…8/2/1996 REVISION KNEE SYSTEM K(043440 2/18/2005 LEGION COBALT CHROME REVISION KNEE K(060742 5/3/'2 006 SYSTEM CROSSLINKED POLYETHYLENE ARTICULAR 1017… | 2006 |
| Kept off the family tree | K070927 | FDA’s K070927 is Hemosil D-Dimer HS Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
| * | K072531 | Legion Stem with HolesSummary page 3…OSSLINKED POLYETHYLENE ARTICULAR 1017 /920 INSERTSK0079//27 LEGION STEM WITH HOLES K072531 12/6/2007 PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS K(963255 1/2/1997… | 2007 |
| * | K963255 | Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial InsertSummary page 3…K0079//27 LEGION STEM WITH HOLES K072531 12/6/2007 PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS K(963255 1/2/1997 TIBIAL INSERT, PROFIX P/S TIBIAL INSERT ______ REVISIQN KNEE SYSTEM… | 1997 |
| * | K041106 | Revision Knee SystemSummary page 3…K(963255 1/2/1997 TIBIAL INSERT, PROFIX P/S TIBIAL INSERT ______ REVISIQN KNEE SYSTEM K041106 7/1/2004 Smith & Nephew Inc. Hinged Total Knee System ______ _______ Descri… | 2004 |
| * | K081111 | Legion Hinge Knee SystemSummary page 3…_______ Description 610(k) JClearance Date LEGION HINGE KNEE SYSTEM K(081111 J 7/23/2008 Device Description Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total… | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2019 | Class II | Z-0878-2020 | Process change control | 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 | Process control | 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 | Error in labeling | One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. |
| Apr 9, 2018 | Class II | Z-1902-2018 | Process control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 41 ancestors have a recall of any class.
- Of its descendants, K123159 (Smith & Nephew, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 31 other devices also cite its predicate K951987.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
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…
Read the full statement (611 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121393: Smith & Nephew, Inc. Total Knee System Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121393
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026