510(k) · Cleared

Cleared

Taper Oxinium Femoral Head

K110101510(k) TraditionalCleared Apr 11, 201188-day reviewClass II21 CFR 888.3353

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

Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 11, 2011 as substantially equivalent to K021673 (Smith & Nephew, Inc., 2002) and 4 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1986. 5 later devices descend from it.

Decided: Apr 11, 2011
Review: 88 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 5

Its longest line of descent runs back 5 generations to K861766 (1986). 24 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
4 generations backK964094 MinifixFerguson Medical · 1996
3 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
2 generations backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
1 generation backK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
This deviceK110101 Taper Oxinium Femoral HeadSmith & Nephew, Inc. · 2011
Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK231448 TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · Recalled
Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 2 generations on0descendants
K231448TANDEM Hip SystemSmith & Nephew, Inc. · 2023 · 2 generations on0descendants
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K861766	Howmedica Hoffmann Fixation Pin System	Howmedica Corp.	1986	—
−4	K964094	Minifix	Ferguson Medical	1996	—
−3	K061253	Reflection 3 Acetabular System	Smith & Nephew, Inc.	2006	—
−2	K070756	Smith and Nephew Reflection 3 Acetabular System	Smith & Nephew, Inc.	2007	6
−1	K092386	R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners	Smith & Nephew, Inc.	2009	—
0 (this device)	K110101	Taper Oxinium Femoral Head	Smith & Nephew, Inc.	2011	—
+1	K211176	Smith & Nephew Hip Systems	Smith & Nephew, Inc.	2022	1
+2	K240783	Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners…	Smith & Nephew, Inc.	2024	—
+2	K242375	OR3O Dual Mobility System	Smith & Nephew, Inc.	2024	—
+2	K231448	TANDEM Hip System	Smith & Nephew, Inc.	2023	1
+1	K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1992	1	0
1993	1	0
1994	1	0
1996	1	0
1997	1	0
1999	2	0
2000	4	0
2001	1	0
2002	3	0
2005	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2022	1	0
2023	1	0
2024	2	0

FIG. 1 — Lineage of K110101, 1986–2024Source: 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (5)

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
*	K021673	Total Hip Femoral Head - 12/14 Taper Summary page 1 …rained cemented or nonporous uncemented prosthesis - Class 11 Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Total Hip Femoral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE…	Smith & Nephew, Inc.	2002	1
*	K072817	Echelon Titanium Hip System Summary page 1 …s - Class 11 Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Total Hip Femoral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liner…	Smith & Nephew, Inc.	2008	—
*	K022902	Smith & Nephew Hip System Summary page 1 …anel Code: Orthopaedics/87 Predicate Devices: Total Hip Femoral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liners (K022958) Device Description Subje…	Smith & Nephew, Inc.	2002	—
*	K092386	R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners Summary page 1 …oral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liners (K022958) Device Description Subject of this Traditional 51 0(k) Premarket Notification are t…	Smith & Nephew, Inc.	2009	—
*	K022958	Total Hip Femoral Heads and Liners Summary page 1 …on Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liners (K022958) Device Description Subject of this Traditional 51 0(k) Premarket Notification are the Smith &Nephew, Inc, 10/12 Taper Oxinium F…	Smith & Nephew, Inc.	2002	1

Also cleared against K021673: 7 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K211176	Smith & Nephew Hip Systems	Smith & Nephew, Inc.	2022	3
K123598	Smith & Nephew, Inc. Hip System Instrumentation	Smith & Nephew, Inc.	2013	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?

The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
6 of the 24 ancestors have a recall of any class.
Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
7 other devices also cite its predicate K021673.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the…

Read the full statement (108 words)

Total hip components are indicated for individuals undergoing primary and revision surgery

where other treatments or devices have failed in rehabilitating hips damaged as a result of

trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative

joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis;

traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant;

nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head

involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone

resection; fracture dislocation of the hip; and correction of deformity. The subject devices are

intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110101 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110101: Taper Oxinium 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/K110101

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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