510(k) · Cleared

Recalled · Class I · 2020

Profemur Hip System Modular Necks

K100866510(k) SpecialCleared Apr 28, 201030-day reviewClass II21 CFR 888.3353Recalls 9 (1 Class I)

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

Wrightmedicaltechnologyinc · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 28, 2010 as substantially equivalent to K091423 (Wrightmedicaltechnologyinc, 2009) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1989. 2 of the 18 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 9 times, including a Class I recall.

Decided: Apr 28, 2010
Review: 30 days
Class: Class II
Product code: LZO
Recalls: 9 (1 Class I)
Predicates: 3

Its longest line of descent runs back 1 generation to K893685 (1989). 3 ancestors in all. 14 later devices descend from it, 4 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK893685 Ceramic Femoral HeadDow Corning Wright · 1989
This deviceK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010
Descendant · cites it directly · 8 of its ownK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
Descendant · cites it directly · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 4 of its ownK150302 PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015
Descendant · cites it directly · 4 of its ownK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 3 of its ownK150133 PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011high 3 (2011) · low 0 (2013)2026

Class I recalls in this family

K091423 Profemur Hip System Modular Necksdirect predicate · 2009

Most influential descendants

Showing 5 of 14 · See all

K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly8descendants
K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly5descendants
K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015 · 2 generations on4descendants
K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly4descendants
K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K893685	Ceramic Femoral Head	Dow Corning Wright	1989	—
0 (this device)	K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2010	—
+1	K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	—
+2	K150302	PROFEMUR Preserve Classic Stem	Microport Orthopedics, Inc.	2015	—
+1	K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	—
+2	K150133	PROFEMUR Preserve Size 1-3 Hip Stems	Microport Orthopedics, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	3	0
2012	2	0
2015	2	0
2018	1	0
2020	2	0
2022	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K100866, 1989–2025Source: 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.

2 devices in this family have a Class I recall. 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

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What was it cleared against? (3)

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
*	K091423	Profemur Hip System Modular Necks Summary page 1 …e device that is the subject of the premarket notification submission: The subject modular femoral necks, manufactured from cobalt chrome alloy, were cleared for use in K091423 with metal femoral heads, but lacked testing for direct assembly to ceramic femoral heads. This 510(k) notification consists of t…	Wrightmedicaltechnologyinc	2009	Class I
*	K081090	Profemur LX 5/8 Coated Hip Stem	Wrightmedicaltechnologyinc	2008	—
*	K893685	Ceramic Femoral Head Summary page 1 …semi-constrained cemented or nonporous uncemented prosthesis Class 11 510(k) K893685 (a)(4) Device Description Description of the device that is the subject of the premarket notification submission: The subject m…	Dow Corning Wright	1989	—

Also cleared against K091423: 8 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	8
K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	5
K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	4
K201519	PROFEMUR® GLADIATOR® Cemented Classic Stem	Microport Orthopedics, Inc.	2020	1

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 31, 2020	Class II	Z-2948-2020	Labeling Change Control	MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent…
Jun 21, 2016	Class III	Z-0683-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0684-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0688-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0687-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0689-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0685-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Jun 21, 2016	Class III	Z-0686-2017	Device Design	Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific…
Aug 4, 2015	Class I	Z-2743-2015	Device Design	Unexpected rate of postoperative fractures resulting in the need for revision surgery.

The 5 latest of 9 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K112080 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 8 descendants of its own.
8 other devices also cite its predicate K091423.

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. 2010, 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?

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed

Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100866 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100866: Profemur Hip System Modular Necks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100866

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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