510(k) · Cleared

Cleared

Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments

K113038510(k) TraditionalCleared Jan 5, 201285-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 Jan 5, 2012 as substantially equivalent to K073175 (Smith & Nephew, Inc., 2007) and 7 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1996.

Decided: Jan 5, 2012
Review: 85 days
Class: Class II
Product code: HSX
Recalls: None
Predicates: 8

Its longest line of descent runs back 5 generations to K962137 (1996). 27 ancestors in all, the oldest K760245 (1976). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
4 generations backK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
3 generations backK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
2 generations backK052265 Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc. · 2005 · Recalled
1 generation backK061569 Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc. · 2006
This deviceK113038 Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee…Smith & Nephew, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K962137	Genesis II Constrained System	Smith & Nephew Richards, Inc.	1996	1
−4	K041106	Revision Knee System	Smith & Nephew, Inc.	2004	1
−3	K043440	Smith & Nephew, Inc. Revision Knee System	Smith & Nephew, Inc.	2005	7
−2	K052265	Smith & Nephew Competitor Duo Knee Femoral	Smith & Nephew, Inc.	2005	42
−1	K061569	Smith & Nephew Competitor Deuce Femoral Components	Smith & Nephew, Inc.	2006	—
0 (this device)	K113038	Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System…	Smith & Nephew, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1976	1	0
1988	1	0
1991	1	0
1993	1	0
1995	1	0
1996	3	0
1998	1	0
1999	1	0
2001	2	0
2003	1	0
2004	3	0
2005	2	0
2006	2	0
2007	1	0
2010	1	0

FIG. 1 — Lineage of K113038, 1996–2012Source: 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? (8)

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
*	K073175	Journey Unicondylar Femoral Implant Summary page 1 …emoral polymer/metal semi-constrained cemented prosthesis Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Journey Unicondylar Femoral Implant (K073175) Unicondylar Femoral Component (K030301) Competitor Deuce (Journey) Femoral Component - Sizes 1-8, Oxinium and CoCr (K…	Smith & Nephew, Inc.	2007	—
*	K030301	Unicondylar Femoral Component Summary page 1 …prosthesis Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Journey Unicondylar Femoral Implant (K073175) Unicondylar Femoral Component (K030301) Competitor Deuce (Journey) Femoral Component - Sizes 1-8, Oxinium and CoCr (K061569) Competitor (Journey) PFJ Patello-…	Smith & Nephew, Inc.	2003	—
*	K061569	Smith & Nephew Competitor Deuce Femoral Components Summary page 1 …rney Unicondylar Femoral Implant (K073175) Unicondylar Femoral Component (K030301) Competitor Deuce (Journey) Femoral Component - Sizes 1-8, Oxinium and CoCr (K061569) Competitor (Journey) PFJ Patello-Femoral Knee Implant (Oxinium) (K051086) Genesis Unicompartmental Knee System (K91 27…	Smith & Nephew, Inc.	2006	—
*	K051086	Smith & Nephew Patello-Femoral Implant Summary page 1 …(K030301) Competitor Deuce (Journey) Femoral Component - Sizes 1-8, Oxinium and CoCr (K061569) Competitor (Journey) PFJ Patello-Femoral Knee Implant (Oxinium) (K051086) Genesis Unicompartmental Knee System (K91 2735) Journey Unicondylar Tibial. Baseplastes (K102069) Competitor Unic…	Smith & Nephew, Inc.	2005	—
*	K912735	Genesis Unicompartmental Knee System Summary page 1 …mponent - Sizes 1-8, Oxinium and CoCr (K061569) Competitor (Journey) PFJ Patello-Femoral Knee Implant (Oxinium) (K051086) Genesis Unicompartmental Knee System (K91 2735) Journey Unicondylar Tibial. Baseplastes (K102069) Competitor Unicondylar Knee Tibia[ Baseplate (K061011) Competit…	Smith & Nephew Richards, Inc.	1991	2
*	K102069	Journey Unicondylar Tibial Baseplates Summary page 1 …petitor (Journey) PFJ Patello-Femoral Knee Implant (Oxinium) (K051086) Genesis Unicompartmental Knee System (K91 2735) Journey Unicondylar Tibial. Baseplastes (K102069) Competitor Unicondylar Knee Tibia[ Baseplate (K061011) Competitor Unicondylar AlI-Poly Tibia[ Baseplate (K061779) De…	Smith & Nephew, Inc.	2010	—
*	K061011	Competitor Unicondylar Knee Tibial Baseplate Summary page 1 …(K051086) Genesis Unicompartmental Knee System (K91 2735) Journey Unicondylar Tibial. Baseplastes (K102069) Competitor Unicondylar Knee Tibia[ Baseplate (K061011) Competitor Unicondylar AlI-Poly Tibia[ Baseplate (K061779) Device Description Subject of this Traditional 510(k) Premark…	Smith & Nephew, Inc.	2006	—
*	K061779	Competitor Unicondylar All-Poly Tibial Baseplate Summary page 1 …Journey Unicondylar Tibial. Baseplastes (K102069) Competitor Unicondylar Knee Tibia[ Baseplate (K061011) Competitor Unicondylar AlI-Poly Tibia[ Baseplate (K061779) Device Description Subject of this Traditional 510(k) Premarket Notification are manual instruments associated with the Smith…	Smith & Nephew, Inc.	2006	—

Also cleared against K073175: 6 other devices →

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 16 years and passes through 2 companies; a new generation was cleared every 10 months on median.
11 of the 27 ancestors have a recall of any class.
6 other devices also cite its predicate K073175.

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. 2012, this device’s year, is highlighted.

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?

Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarhritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed: and 4. Treatment of fractures that are unmanageable using other techniques Smith and Nephew…

Read the full statement (208 words)

Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarhritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. Treatment of fractures that are unmanageable using other techniques

Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by adevice that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

" Post-traumatic arthritis;

" Degenerative arthiritis; and

* Failed osteotomies, hemniarthroplasties; and unicompartmental replacement

These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:I

1. Degenerative arthritis in the distal femur and patella.

2. A history of patellar dislocation or patellar fracture.

3. Failed previous surgery (arthroplasty, tibia[ tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113038: Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113038

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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