510(k) Report

510(k) · Cleared

Cleared

Journey Unicondylar Tibial Baseplates

K102069510(k) TraditionalCleared Oct 5, 201074-day reviewClass II21 CFR 888.3520

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Oct 5, 2010 as substantially equivalent to K912735 (Smith & Nephew Richards, Inc., 1991) after a 74-day review. Its family tree reaches back 1 generation to 1991. 43 later devices descend from it.

Decided
Oct 5, 2010
Review
74 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K912735 (1991). 43 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2019: 6 descendants cleared2012: 2 descendants cleared2017: 3 descendants cleared2023: 6 descendants cleared2015: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2021: 10 descendants cleared2025: 2 descendants cleared2024: 3 descendants cleared2022: 3 descendants cleared2026: 2 descendants cleared2020: 3 descendants clearedK912735 · Genesis Unicompartmental Knee System · Smith & Nephew Richards, Inc. · 1991 · recalled1990200020102020
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 14 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants K912735 · Genesis Unicompartmental Knee System · Smith & Nephew Richards, Inc. · 1991 · recalled0+5
  1. Root · 1 generation backK912735 Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc. · 1991 · Recalled
  2. This deviceK102069 Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc. · 2010
  3. Descendant · cites it directly · 27 of its ownK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
  4. Descendant · 2 generations on · 25 of its ownK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
  5. Descendant · 2 generations on · 16 of its ownK133256 Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement…Conformis, Inc. · 2014 · Recalled
  6. Descendant · 3 generations on · 15 of its ownK193105 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee…Conformis, Inc. · 2020
  7. Descendant · 4 generations on · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12014: 12015: 12017: 32019: 62020: 32021: 102022: 32023: 62024: 32025: 22026: 2
2012high 10 (2021) · low 0 (2016)2026

Most influential descendants

Showing 5 of 43 · See all
  • K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012 · cites it directly27descendants
  • K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on25descendants
  • K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc. · 2014 · 2 generations on16descendants
  • K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc. · 2020 · 3 generations on15descendants
  • K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · 4 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912735Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc.19912
0 (this device)K102069Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc.2010—
+1K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.2012—
+2K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.20133
+2K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.20146
+3K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair…Conformis, Inc.2020—
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201410
201510
201730
201960
202030
2021100
202230
202360
202430
202520
202620
FIG. 1 — Lineage of K102069, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K912735Genesis Unicompartmental Knee System
Summary page 1
…baseplates have been designed and developed by Smith & Nephew Orthopaedics. Inkeeping with the design philosophy of the predicate Genesis Unicondylar Tibial Baseplates (K91 2735), the subject devices share the same design features such as: * Shape (footprint) * Size Offering (6sizes with each…
Smith & Nephew Richards, Inc.19912

Also cleared against K912735: 8 other devices →

What descends from it? (43)

See all 43

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227
K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178
K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158
K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.20197
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233
K162084MOTO Partial Knee SystemMedacta International S.A.20173
K183029MOTO Partial Knee SystemMedacta International S.A.20192
K161741GMK UniMedacta International S.A.20172
K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120

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?

  • Its one ancestor has a recall.
  • Of its descendants, K121974 (Conformis, Inc., 2012) has gone furthest, with 27 descendants of its own.
  • 8 other devices also cite its predicate K912735.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HSX

4in 2025

2007: 62008: 42009: 22010: 32011: 12012: 52013: 22015: 12016: 32017: 52018: 22019: 72020: 42021: 72022: 22023: 12024: 42025: 42026 (partial year): 2
2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007: 33 days median2008: 102 days median2010: 74 days median2012: 88 days median2016: 147 days median2017: 160 days median2019: 90 days median2020: 40 days median2021: 81 days median2024: 133 days median2025: 59 days median
2007high 160 (2017) · low 33 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSX

2in 2020

2009: 492013: 12016: 12017: 42020: 2
2007high 49 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSX

175in 2025

2007: 62008: 42009: 212010: 582011: 1142012: 832013: 792014: 662015: 572016: 1072017: 1132018: 1592019: 1772020: 2732021: 2402022: 2572023: 2312024: 1722025: 175
2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763306
2008410204
20092—4921
2010374058
20111—0114
2012588083
20132—179
20140—066
20151—057
201631471107
201751604113
20182—0159
20197900177
20204402273
20217810240
20222—0257
20231—0231
202441330172
20254590175
20262—0—

What is it indicated for?

The Journey Unicondylar Tilbial Baseplates 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 procedures where other treatments or devices have failed; and

*Treatment of fractures that are unmanageable using other techniques.

The implants are labeled for single use only. The tibial baseplates are designed to be implanted using bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K912735

8 other devices cite the same predicate.

  • K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems…Smith & Nephew, Inc. · 20231 recall
  • K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
  • K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc. · 2012
  • K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC · 2010
  • K100197Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc. · 2010
  • K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in HSX

The HSX category page

  • K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
  • K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 2026
  • K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
  • K251834Persona Partial KneeZimmer Biomet · 2025
  • K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025

https://510kreport.com/device/K102069 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102069: Journey Unicondylar Tibial Baseplates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102069

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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