510(k) · Cleared
ClearedJOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith+Nephew, Inc. · NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Cleared on Oct 28, 2022 as substantially equivalent to K190439 (Engage Uni, LLC, 2019) and 2 other predicates after a 57-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Oct 28, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- NJD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K810258 (1981). 127 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- This deviceK222653 JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 5 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 4 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
- This deviceK222653 JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −5 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −4 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| −3 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| −2 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| −1 | K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
| 0 (this device) | K222653 | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | Smith+Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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 NJD? 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 NJD device
- #1 K242307 ACHIEVE Partial Knee Systemscore 13.6 · 8 generations · no Class I recall
- #2 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190439 | Engage™ Partial Knee SystemSummary page 6…Page 5-1 K222653 Page 2 of 7 Predicate Device: Primary Predicate: Engage™ Partial Knee System - K190439 Secondary Predicate: Journey II Unicompartmental Knee Syste… | 2019 |
| * | K190085 | Journey II Unicompartmental Knee SystemSummary page 6…Secondary Predicate: Journey II Unicompartmental Knee System (Journey II UK) –K190085 Journey II Unicompartmental Knee System (Journey II UK) – K… | 2019 |
| * | K191211 | JOURNEY II Unicompartmental Knee SystemSummary page 6…II UK) –K190085 Journey II Unicompartmental Knee System (Journey II UK) – K191211 Device Description The purpose of this Traditional 510(k) submission is to seek FDA clearance of the existing devices ENGAGE™… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 50 of the 127 ancestors have a recall of any class.
- 1 other device also cites its predicate K190439.
How does its category compare?
All NJD devicesNJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NJD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NJD
Too few NJD 510(k)s in any year since 2007 to give a median.
Recalls per year · NJD
No recall names NJD since 2007.
Adverse event reports per year · NJD
4in 2025
MAUDE reports naming product code NJD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for JOURNEY II Unicompartmental Knee System: Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; - Correction of functional deformity; - Revision of previous arthroplasty procedures; - Treatment of fractures that are unmanageable using other techniques.…
Read the full statement (206 words)
Indications for JOURNEY II Unicompartmental Knee System:
Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision of previous arthroplasty procedures;
- Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single-use only and intended for implantation only with bone cement.
Indications for ENGAGE™ Partial Knee System:
The ENGAGE™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis.
- Revision of previous unsuccessful surgical procedures including prior unicompartmental knee arthroplasty
- As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
The femoral component and tibial tray are intended for cementless or cemented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.
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/K222653 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222653: JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222653
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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