510(k) · Cleared

Cleared

Genesis II Total Knee System

K030612510(k) AbbreviatedCleared May 27, 200390-day reviewClass II21 CFR 888.3565

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

Smith & Nephew, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on May 27, 2003 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995. 141 later devices descend from it.

Decided: May 27, 2003
Review: 90 days
Class: Class II
Product code: MBH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951987 (1995). 2 ancestors in all. 141 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
This deviceK030612 Genesis II Total Knee SystemSmith & Nephew, Inc. · 2003
Descendant · cites it directly · 76 of its ownK032295 Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · Recalled
Descendant · cites it directly · 75 of its ownK041825 Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular…Smith & Nephew, Inc. · 2005
Descendant · 2 generations on · 66 of its ownK071071 Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · Recalled
Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
Descendant · cites it directly · 50 of its ownK073325 Legion Porous PrimarySmith & Nephew, Inc. · 2007

Showing 5 of 141 descendants. See all descendants

Descendants cleared per year

2003high 14 (2026) · low 1 (2008)2026

Most influential descendants

Showing 5 of 141 · See all

K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. · 2003 · cites it directly76descendants
K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc. · 2005 · cites it directly75descendants
K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc. · 2007 · 2 generations on66descendants
K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
K073325Legion Porous PrimarySmith & Nephew, Inc. · 2007 · cites it directly50descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
0 (this device)	K030612	Genesis II Total Knee System	Smith & Nephew, Inc.	2003	—
+1	K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	2003	6
+1	K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	2005	—
+2	K071071	Crosslinked Polyethylene Articular Inserts	Smith & Nephew, Inc.	2007	5
+1	K033489	Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee…	Biomet, Inc.	2004	—
+1	K073325	Legion Porous Primary	Smith & Nephew, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	2	0
2006	2	0
2007	2	0
2008	1	0
2009	1	0
2010	4	0
2011	4	0
2012	5	0
2013	7	0
2014	8	0
2015	10	0
2016	2	0
2017	5	0
2018	5	0
2019	9	0
2020	6	0
2021	10	0
2022	9	0
2023	9	0
2024	12	0
2025	10	0
2026	14	0

FIG. 1 — Lineage of K030612, 1995–2026Source: 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 MBH? 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 MBH device

#1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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
*	K951987	Genesis II Total Knee System Summary page 1 …ts of the Genesis I1 Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis I1 Total Knee Systems cleared via K95 1987 and K953274. The subject components are porous coated metal alloy devices. Device Classification Name 21 CFR 888.3565 (MBH) Knee…	Smith & Nephew Richards, Inc.	1995	6
*	K953274	Genesis Porous Tibial Trays & Revision Knee System Summary page 1 …esis I1 Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis I1 Total Knee Systems cleared via K95 1987 and K953274. The subject components are porous coated metal alloy devices. Device Classification Name 21 CFR 888.3565 (MBH) Knee joint patel…	Smith & Nephew Richards, Inc.	1996	—

Also cleared against K951987: 31 other devices →

What descends from it? (141)

See all 141

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

Number	Device	Applicant	Decided	Descendants
K032295	Genesis II Posterior Stabilized High Flexion Articular Insert	Smith & Nephew, Inc.	2003	76
K041825	Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert	Smith & Nephew, Inc.	2005	75
K033489	Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…	Biomet, Inc.	2004	60
K073325	Legion Porous Primary	Smith & Nephew, Inc.	2007	50
K032683	Genesis II Porous Plus HA Knee System	Smith & Nephew, Inc.	2003	19
K190577	World Knee Total Knee Systems	Signature Orthopaedics Pty, Ltd.	2019	5
K121393	Smith & Nephew, Inc. Total Knee System Instrumentation	Smith & Nephew, Inc.	2012	5
K140075	U2 Femoral Component, CR, Porous Coated	United Orthopedic Corp.	2014	3
K261462	LANDMARK Total Knee System	Smith & Nephew, Inc.	2026	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, K032295 (Smith & Nephew, Inc., 2003) has gone furthest, with 76 descendants of its own.
31 other devices also cite its predicate K951987.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007high 209 (2009) · low 48 (2021)2026

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

Recalls per year · MBH

1in 2024

2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, 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	10	59	0	27
2008	3	70	0	21
2009	3	209	2	89
2010	4	84	0	121
2011	5	84	15	247
2012	5	90	1 (1)	370
2013	6	138	4 (4)	308
2014	9	114	0	385
2015	8	100	0	955
2016	4	74	1	1,034
2017	4	115	9	1,007
2018	6	89	1	1,191
2019	1	—	1	1,394
2020	7	112	2	1,089
2021	6	48	0	1,539
2022	7	57	0	1,261
2023	6	94	2	1,263
2024	10	84	1	1,497
2025	8	98	0	1,561
2026	7	153	4	—

What is it indicated for?

The porous components of the Genesis I1 Total Knee System are single use devices for

use without cement. The devices are indicated for:

1. Rheumatoid arthritis.

Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older

patients whose age, weight, and activity levels are compatible with an

adequate long-term result.

3. Failed osteotomies, unicompartmental replacement, or total knee

replacement.

The posterior stabilized knee system is designed for use in patients in primary

and revision surgery, where the anterior and posteriorguciate ligaments are

incompetent and the collateral ligaments remain intact.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030612 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030612: Genesis II Total 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/K030612

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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