510(k) · Cleared
Recalled · Class II · 2017Legion Cone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 13, 2017 as substantially equivalent to K053340 (Zimmer Trabecular, 2006) and 4 other predicates after a 102-day review. Its family tree reaches back 8 generations to 1985. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 13, 2017
- Review
- 102 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 8 generations to K850055 (1985). 33 ancestors in all, the oldest K840643 (1984). 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- 5 generations backK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- 4 generations backK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
- 3 generations backK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK123012 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2012
- This deviceK162775 Legion Cone SystemSmith & Nephew, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK180334 LEGION Knee SystemSmith & Nephew, Inc. · 2018
- 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 · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242711 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K180334LEGION Knee SystemSmith & Nephew, Inc. · 2018 · cites it directly4descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| −5 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| −4 | K072417 | Smith & Nephew Mis Hip Stem | Smith & Nephew, Inc. | 2008 | 1 |
| −3 | K080625 | Smith & Nephew Mis Hip Stem with Stiktite | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K103256 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2011 | 2 |
| −1 | K123012 | Smith & Nephew SMF Hip Stem | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K162775 | Legion Cone System | Smith & Nephew, Inc. | 2017 | — |
| +1 | K180334 | LEGION Knee System | Smith & Nephew, Inc. | 2018 | — |
| +1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +2 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
| +2 | K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsSummary page 4…s. The Legion Tibial and Femoral Cones are similar to the primary predicate Zimmer Trabecular™ Metal Tibial and Femoral Cone Augments cleared via premarket notification K053340. The Legion Tibial Cones will be available in heights of 25mm (short) and 40mm (long) and inner diameters (ID) of 18mm-30mm, in 2… | 2006 |
| * | K080625 | Smith & Nephew Mis Hip Stem with StiktiteSummary page 5…ric (Stiktite™) porous coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625, K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identi… | 2008 |
| * | K103256 | Smith & Nephew SMF Hip StemSummary page 5…tite™) porous coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625, K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identical to th… | 2011 |
| * | K123012 | Smith & Nephew SMF Hip StemSummary page 5…coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625, K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identical to the grit- blast… | 2012 |
| * | K951987 | Genesis II Total Knee SystemSummary page 5…on identical to the grit- blasted surface of reference predicate Smith & Nephew Genesis Il Total Knee System cement-on-augment devices cleared via premarket notification K951987. Intended Use The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones… | 1995 |
What descends from it? (5)
2 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 |
|---|---|---|---|---|
| May 30, 2017 | Class II | Z-2625-2017 | Process control | The incorrect Loctite adhesive was used to assemble the impactor heads. |
| May 30, 2017 | Class II | Z-2624-2017 | Process control | The incorrect Loctite adhesive was used to assemble the impactor heads. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 15 of the 32 ancestors have a recall of any class.
- Of its descendants, K180334 (Smith & Nephew, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K053340.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, ot total knee replacement. 4, Postetior stabilized knee systers are designed for use in patients in primary and revision surgery, where the anterior and…
Read the full statement (166 words)
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following:
1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, ot total knee replacement.
4, Postetior stabilized knee systers 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 infact.
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) ate 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 of incompetent.
These are single use implants and are intended for use with and without bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162775: Legion Cone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162775
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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