510(k) · Cleared
Recalled · Class II · 2018Legion Hinge Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Jul 23, 2008 as substantially equivalent to K023667 (Plus Orthopedics, 2002) and 1 other predicate after a 96-day review. Its family tree reaches back 3 generations to 2001. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 23, 2008
- Review
- 96 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003504 (2001). 5 ancestors in all, the oldest K945028 (1996). 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003504 RT-Plus Modular Cemented Knee ComponentsPlus Orthopedics · 2001
- 2 generations backK013340 RT-Plus Knee Additional ComponentsPlus Orthopedics · 2001
- 1 generation backK023667 RT-Plus Solution & RT-Plus Modular Solution KneePlus Orthopedics · 2002
- This deviceK081111 Legion Hinge Knee SystemSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK121393 Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK151118 Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015
- Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK123159 Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK173331 JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew · 2015 · cites it directly4descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc. · 2013 · 2 generations on2descendants
- K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003504 | RT-Plus Modular Cemented Knee Components | Plus Orthopedics | 2001 | — |
| −2 | K013340 | RT-Plus Knee Additional Components | Plus Orthopedics | 2001 | — |
| −1 | K023667 | RT-Plus Solution & RT-Plus Modular Solution Knee | Plus Orthopedics | 2002 | — |
| 0 (this device) | K081111 | Legion Hinge Knee System | Smith & Nephew, Inc. | 2008 | — |
| +1 | K121393 | Smith & Nephew, Inc. Total Knee System Instrumentation | Smith & Nephew, Inc. | 2012 | 4 |
| +1 | K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew | 2015 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K123159 | Smith & Newphew, Inc. Disposable Knee Instruments | Smith & Nephew, Inc. | 2013 | — |
| +2 | K173331 | JOURNEY II XR Knee Instruments | Smith & Nephew, Inc. | 2017 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| Kept off the family tree | K002757 | FDA’s K002757 is Oncology Salvage System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K023667 | RT-Plus Solution & RT-Plus Modular Solution KneeSummary page 2…Orthopaedic Salvage System K02757 11/24/2000 (OSS) Plus Orthopedics AG RT PLUS Solution System K023667 12/24/2000 Zimmer Nexgen Complete Knee K013385 1/9/2002… | 2002 |
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 2…(OSS) Plus Orthopedics AG RT PLUS Solution System K023667 12/24/2000 Zimmer Nexgen Complete Knee K013385 1/9/2002 Solution Rotating Hinge Knee E. SUMMARY OF TECHNOLOGICAL COMPARISON: T… | 2002 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Feb 1, 2018 | Class II | Z-1105-2018 | Process control | The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5. |
| May 26, 2016 | Class II | Z-2092-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| May 26, 2016 | Class II | Z-2093-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| May 26, 2016 | Class II | Z-2090-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| May 26, 2016 | Class II | Z-2091-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| May 26, 2016 | Class II | Z-2094-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| May 26, 2016 | Class II | Z-2095-2016 | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K121393 (Smith & Nephew, Inc., 2012) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K023667.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 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…
Read the full statement (117 words)
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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 and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081111 · printed Nov 3, 2026
Cite this page
510(k) Report. “K081111: Legion Hinge Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081111
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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