510(k) · Cleared

Cleared

Competitor Unicondylar Knee Tibial Baseplate

K061011510(k) AbbreviatedCleared Jul 11, 200690-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 Jul 11, 2006 as substantially equivalent to K912735 (Smith & Nephew Richards, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.

Decided: Jul 11, 2006
Review: 90 days
Class: Class II
Product code: HSX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K912735 (1991). 2 ancestors in all. 11 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK912735 Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc. · 1991 · Recalled
This deviceK061011 Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc. · 2006
Descendant · cites it directly · 8 of its ownK152315 JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015
Descendant · 2 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
Descendant · cites it directly · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
Descendant · 3 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
Descendant · 2 generations on · 0 of its ownK261462 LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010high 3 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all

K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc. · 2015 · cites it directly8descendants
K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 2 generations on7descendants
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · cites it directly3descendants
K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on1descendant
K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912735	Genesis Unicompartmental Knee System	Smith & Nephew Richards, Inc.	1991	2
0 (this device)	K061011	Competitor Unicondylar Knee Tibial Baseplate	Smith & Nephew, Inc.	2006	—
+1	K152315	JOURNEY II Uni Tibial Base and Insert	Smith & Nephew, Inc.	2015	—
+2	K190085	Journey II Unicompartmental Knee System	Smith & Nephew, Inc.	2019	3
+1	K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System…	Smith & Nephew, Inc.	2023	1
+3	K191211	JOURNEY II Unicompartmental Knee System	Smith & Nephew, Inc.	2019	—
+2	K261462	LANDMARK Total Knee System	Smith & Nephew, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2015	1	0
2019	2	0
2022	1	0
2023	1	0
2024	3	0
2026	1	0

FIG. 1 — Lineage of K061011, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K912735	Genesis Unicompartmental Knee System Summary page 1 …ar to the following commercially available devices regarding design features, overall indications, and materials: * Smith & Nephew Genesis Unicompartmental Knee System (K91 2735) Smith & Nephew Unicondylar Femoral Component (K(030301) DEPARTMENT OF HEALTH & HUMAN SERVICES…	Smith & Nephew Richards, Inc.	1991	2
*	K030301	Unicondylar Femoral Component Summary page 1 …design features, overall indications, and materials: * Smith & Nephew Genesis Unicompartmental Knee System (K91 2735) Smith & Nephew Unicondylar Femoral Component (K(030301) DEPARTMENT OF HEALTH & HUMAN SERVICES…	Smith & Nephew, Inc.	2003	—

Also cleared against K912735: 8 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K152315	JOURNEY II Uni Tibial Base and Insert	Smith & Nephew, Inc.	2015	8
K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…	Smith & Nephew, Inc.	2023	3
K113038	Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments	Smith & Nephew, Inc.	2012	0
K100197	Genesis Unicondylar Uhmwpe Articular Inserts	Smith & Nephew, Inc.	2010	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K152315 (Smith & Nephew, Inc., 2015) has gone furthest, with 8 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.

FDA decisions per year · HSX

4in 2025

2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007high 160 (2017) · low 33 (2007)2026

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

Recalls per year · HSX

2in 2020

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

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

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 Competitor Unicondylar Tibial Baseplate Components 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

The baseplate components are for single use only and are intended for implantation only with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061011 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061011: Competitor Unicondylar Knee Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061011

Report an extraction error

Are you the manufacturer?

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