510(k) Report

510(k) · Cleared

Recalled · 2004

Genesis Unicompartmental Knee System

K912735510(k) TraditionalCleared Dec 27, 1991190-day reviewClass II21 CFR 888.3520Recalls 2

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

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

Cleared on Dec 27, 1991 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 52 later devices descend from it. It has been recalled 2 times.

Decided
Dec 27, 1991
Review
190 days
Class
Class II
Product code
HSX
Recalls
2
Predicates
0

52 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2012: 2 descendants cleared2010: 3 descendants cleared2006: 2 descendants cleared2023: 6 descendants cleared2015: 1 descendant cleared2019: 7 descendants cleared2017: 3 descendants cleared2008: 1 descendant cleared2024: 3 descendants cleared2026: 2 descendants cleared2016: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2021: 10 descendants cleared2025: 2 descendants cleared2022: 3 descendants cleared2020: 3 descendants cleared1990200020102020
  1. This deviceK912735 Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc. · 1991
  2. Descendant · cites it directly · 43 of its ownK102069 Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc. · 2010
  3. Descendant · 2 generations on · 27 of its ownK121974 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012
  4. Descendant · cites it directly · 26 of its ownK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
  5. Descendant · 3 generations on · 25 of its ownK132640 Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · Recalled
  6. Descendant · 2 generations on · 18 of its ownK081351 Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 12010: 32012: 22013: 12014: 12015: 12016: 12017: 32019: 72020: 32021: 102022: 32023: 62024: 32025: 22026: 2
2006high 10 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 52 · See all
  • K102069Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc. · 2010 · cites it directly43descendants
  • K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2012 · 2 generations on27descendants
  • K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007 · cites it directly26descendants
  • K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2013 · 3 generations on25descendants
  • K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2008 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912735Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc.1991—
+1K102069Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc.2010—
+2K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.2012—
+1K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.2007—
+3K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.20133
+2K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200810
201030
201220
201310
201410
201510
201610
201730
201970
202030
2021100
202230
202360
202430
202520
202620
FIG. 1 — Lineage of K912735, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (52)

See all 52

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

NumberDeviceApplicantDecidedDescendants
K102069Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc.201043
K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726
K061011Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc.200611
K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158
K061779Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc.20065
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.20233
K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120
K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC20100
K100197Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 21, 2004Not classifiedZ-0305-05OtherThe firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
Jun 21, 2004Not classifiedZ-0304-05OtherThe firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K102069 (Smith & Nephew, Inc., 2010) has gone furthest, with 43 descendants of its own.

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.

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—

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

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/K912735 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912735: Genesis Unicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912735

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026