510(k) · Cleared

Recalled · Class I · 2020

Profemur Hip System Modular Necks

K091423510(k) TraditionalCleared Aug 25, 2009104-day reviewClass III21 CFR 888.3330Recalls 2 (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 · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Aug 25, 2009 after a 104-day review. The FDA summary names no predicate by number. 2 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it. It has been recalled 2 times, including a Class I recall.

Decided: Aug 25, 2009
Review: 104 days
Class: Class III
Product code: KWA
Recalls: 2 (1 Class I)
Predicates: 0

36 later devices descend from it, 9 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.

This deviceK091423 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009
Descendant · cites it directly · 14 of its ownK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Recalled (Class I)
Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
Descendant · cites it directly · 8 of its ownK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
Descendant · cites it directly · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2010high 5 (2011) · low 0 (2013)2026

Class I recalls in this family

K100866 Profemur Hip System Modular Neckscites it directly · 2010

Most influential descendants

Showing 5 of 36 · See all

K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · cites it directly14descendants
K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly8descendants
K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K091423	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2009	—
+1	K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2010	Class I
+1	K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…	Lima Corporate S.P.A.	2012	—
+1	K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	—
+2	K141327	Minima S System	Lima Corporate S.P.A.	2014	—
+1	K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1
2011	5	0
2012	5	0
2014	3	0
2015	5	0
2016	2	0
2017	1	0
2018	1	0
2019	1	0
2020	2	0
2021	2	0
2022	1	0
2023	1	0
2024	3	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K091423, 2009–2026Source: 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.

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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K100866	Profemur Hip System Modular Necks Class I	Wrightmedicaltechnologyinc	2010	14
K112158	Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads	Lima Corporate S.P.A.	2012	13
K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	8
K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	5
K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	4
K102172	Msa Hip System	Global Manufacturing Technology	2011	3
K112682	Metha Hip System	Aesculap Implant Systems, LLC	2012	2
K201519	PROFEMUR® GLADIATOR® Cemented Classic Stem	Microport Orthopedics, Inc.	2020	1
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	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…
Aug 4, 2015	Class I	Z-2743-2015	Device Design	Unexpected rate of postoperative fractures resulting in the need for revision surgery.

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.

K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K100866 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 14 descendants of its own.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWA

4in 2012

2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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	8	74	0	213
2008	9	57	13	762
2009	7	139	0	820
2010	6	167	84	3,348
2011	11	101	28	17,737
2012	4	76	21	24,601
2013	0	—	1	20,020
2014	0	—	0	16,494
2015	0	—	0	12,339
2016	0	—	1	7,872
2017	0	—	1	6,847
2018	0	—	1	6,388
2019	0	—	2	7,628
2020	0	—	1	4,538
2021	0	—	0	2,064
2022	0	—	0	1,617
2023	0	—	19	1,474
2024	0	—	0	1,168
2025	0	—	0	1,216
2026	0	—	0	—

What is it indicated for?

The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammato1y degenerative joint disease such as osteoartlhitis, 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/K091423 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091423: Profemur Hip System Modular Necks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091423

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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