510(k) · Cleared
ClearedZUK Select Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jun 15, 2016 as substantially equivalent to K122529 (Zimmer, Inc., 2012) and 4 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1981. 8 later devices descend from it.
- Decided
- Jun 15, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K810258 (1981). 75 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 1 generation backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- This deviceK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 1 generation backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- This deviceK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · cites it directly7descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
- K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · cites it directly1descendant
- K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 3 generations on0descendants
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −6 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −5 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −4 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −3 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −2 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −1 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| +1 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +2 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +1 | K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
| +3 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026 | — |
| +3 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 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? (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 |
|---|---|---|---|
| * | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceSummary page 8…es to the ZUK Select Knee System . Submission Clearance ‘ ‘.Manufacturer ; ‘Descnptlon . Number | = Dats: Zimmer Unicompartmental Zimmer Knee System Vivacit-E Articular K122529 11/16/2012 Surface Smith & Nephew, Inc. | Journey Select Knee System K093056 12/15/2009 Smith & Nephew, Inc. fg‘;{gfit" Unicondyta… | 2012 |
| * | K093056 | Smith & Nephew, Inc. Journey Select Knee SystemSummary page 8…Descnptlon . Number | = Dats: Zimmer Unicompartmental Zimmer Knee System Vivacit-E Articular K122529 11/16/2012 Surface Smith & Nephew, Inc. | Journey Select Knee System K093056 12/15/2009 Smith & Nephew, Inc. fg‘;{gfit" Unicondytar Femoral K081351 | 07/24/2008 Smith & Nephew, Inc. | Patelio-Femoral Knee Im… | 2009 |
| * | K081351 | Modification to Journey Unicondylar Femoral ImplantSummary page 8…em Vivacit-E Articular K122529 11/16/2012 Surface Smith & Nephew, Inc. | Journey Select Knee System K093056 12/15/2009 Smith & Nephew, Inc. fg‘;{gfit" Unicondytar Femoral K081351 | 07/24/2008 Smith & Nephew, Inc. | Patelio-Femoral Knee Implant K051086 05/31/2005 . Zimmer Unicompartmental Zimmer Knee System… | 2008 |
| * | K051086 | Smith & Nephew Patello-Femoral ImplantSummary page 8…Journey Select Knee System K093056 12/15/2009 Smith & Nephew, Inc. fg‘;{gfit" Unicondytar Femoral K081351 | 07/24/2008 Smith & Nephew, Inc. | Patelio-Femoral Knee Implant K051086 05/31/2005 . Zimmer Unicompartmental Zimmer Knee System K033363 01/16/2004 Conclusion No new or modified knee implant components… | 2005 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 8…c. fg‘;{gfit" Unicondytar Femoral K081351 | 07/24/2008 Smith & Nephew, Inc. | Patelio-Femoral Knee Implant K051086 05/31/2005 . Zimmer Unicompartmental Zimmer Knee System K033363 01/16/2004 Conclusion No new or modified knee implant components or device specific instruments are being introduced as a result… | 2004 |
What descends from it? (8)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 26 of the 75 ancestors have a recall of any class.
- Of its descendants, K190085 (Smith & Nephew, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K122529.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ZUK Unicompartmental Knee System is indicated for patients with: -Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. -Previous tibial condyle or plateau fractures with loss of anatomy or function. -Varus or valgus deformities. -Revision of previous arthroplasty procedures. -These devices are indicated for cemented use only. -The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to…
Read the full statement (283 words)
The ZUK Unicompartmental Knee System is indicated for patients with:
-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-Previous tibial condyle or plateau fractures with loss of anatomy or function.
-Varus or valgus deformities.
-Revision of previous arthroplasty procedures.
-These devices are indicated for cemented use only.
-The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Indications for JOURNEY Unicompartmental Knee Replacement:
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
• Noninflammatory 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. HA coated unicompartmental knee implants are available outside the US for use without bone cement.
Indications for JOURNEY Patello-Femoral Replacement:
• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or patellar fracture; and
• Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew patello-femoral implants are intended for implantation with bone cement.
Indications for Combined Unicompartmental and Patello-Femoral Replacement:
• Post-traumatic arthritis;
• Degenerative arthritis; and
• Failed osteotomies and unicompartmental replacement
These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with 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/K160738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160738: ZUK Select Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160738
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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