510(k) · Cleared

Recalled · Class II · 2015

Smith & Nephew Modular Femoral Head

K061243510(k) AbbreviatedCleared Jul 17, 200675-day reviewClass II21 CFR 888.3360Recalls 1

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

Smith & Nephew, Inc. · KWL Prosthesis, Hip, Hemi-, Femoral, Metal

Cleared on Jul 17, 2006 as substantially equivalent to K896580 (Richards Medical Co., Inc., 1990) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1990. 19 later devices descend from it. It has been recalled once.

Decided: Jul 17, 2006
Review: 75 days
Class: Class II
Product code: KWL
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K896580 (1990). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK896580 Uni-Polar HeadRichards Medical Co., Inc. · 1990
This deviceK061243 Smith & Nephew Modular Femoral HeadSmith & Nephew, Inc. · 2006
Descendant · cites it directly · 18 of its ownK062408 Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006
Descendant · 2 generations on · 16 of its ownK093363 Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010
Descendant · 3 generations on · 7 of its ownK113848 R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · Recalled
Descendant · 3 generations on · 6 of its ownK161233 OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016
Descendant · 3 generations on · 6 of its ownK102370 R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 19 · See all

K062408Smith & Nephew Modular Femoral (Hemi) HeadSmith & Nephew, Inc. · 2006 · cites it directly18descendants
K093363Cocr and Oxinium Femoral Heads and R3 Xlpe LinersSmith & Nephew, Inc. · 2010 · 2 generations on16descendants
K113848R3 Xlpe LinersSmith & Nephew, Inc. · 2012 · 3 generations on7descendants
K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc. · 2016 · 3 generations on6descendants
K102370R3 Xlpe Anteverted LinersSmith & Nephew, Inc. · 2011 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896580	Uni-Polar Head	Richards Medical Co., Inc.	1990	—
0 (this device)	K061243	Smith & Nephew Modular Femoral Head	Smith & Nephew, Inc.	2006	—
+1	K062408	Smith & Nephew Modular Femoral (Hemi) Head	Smith & Nephew, Inc.	2006	—
+2	K093363	Cocr and Oxinium Femoral Heads and R3 Xlpe Liners	Smith & Nephew, Inc.	2010	—
+3	K113848	R3 Xlpe Liners	Smith & Nephew, Inc.	2012	2
+3	K161233	OXINIUM DH Fermoral Heads	Smith & Nephew, Inc.	2016	—
+3	K102370	R3 Xlpe Anteverted Liners	Smith & Nephew, Inc.	2011	—

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
2006	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2016	1	0
2017	1	0
2018	1	0
2019	1	0
2022	3	0
2023	2	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K061243, 1990–2026Source: 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 KWL? 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 KWL device

#1 K253675 OsteoRemedies Hip Spacer Systemscore 16.0 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K896580	Uni-Polar Head Summary page 1 …to be used in conjunction with existing Smith & Nephew femoral components. The overall designs of the cornponents are based upon existing Uni-polar implants subject of K896580. C. SUBSTANTIAL EQUIVALENCE INFORMATION: The Smith & Nephew Modular Femoral Heads are similar to the following commercially av…	Richards Medical Co., Inc.	1990	—
*	K023743	Smith & Nephew Global Bipolar System	Smith & Nephew, Inc.	2003	3

Also cleared against K896580: 7 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K062408	Smith & Nephew Modular Femoral (Hemi) Head	Smith & Nephew, Inc.	2006	18
K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 16, 2015	Class II	Z-0584-2016	Labeling design	The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for…

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, K062408 (Smith & Nephew, Inc., 2006) has gone furthest, with 18 descendants of its own.
7 other devices also cite its predicate K896580.

How does its category compare?

All KWL devices

KWL Prosthesis, Hip, Hemi-, Femoral, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWL

3in 2025

2007high 3 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWL

32in 2025

2007high 32 (2025)2026

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

Recalls per year · KWL

2in 2017

2007high 36 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KWL

29in 2025

2007high 415 (2019) · low 11 (2007)2025

MAUDE reports naming product code KWL, 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	2	—	36	11
2008	1	—	0	13
2009	0	—	2	21
2010	0	—	0	55
2011	2	—	0	51
2012	1	—	0	62
2013	0	—	0	89
2014	0	—	0	107
2015	1	—	1	223
2016	0	—	0	210
2017	0	—	2	347
2018	2	—	0	294
2019	1	—	0	415
2020	1	—	0	270
2021	0	—	0	107
2022	1	—	0	99
2023	0	—	0	48
2024	1	—	0	143
2025	3	32	0	29
2026	2	—	1	—

What is it indicated for?

The Smith & Nephew Modular Femoral Heads are indicated for the following: * Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; * rheumatoid arthritis; * arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; * revision procedures where other treatments have failed; and *…

Read the full statement (108 words)

The Smith & Nephew Modular Femoral Heads are indicated for the following:

* Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;

* rheumatoid arthritis;

* arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;

* revision procedures where other treatments have failed; and

* treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061243 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061243: Smith & Nephew Modular Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061243

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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