510(k) · Cleared

Cleared

Profemur Gladiator HA Hip Stem

K112150510(k) TraditionalCleared Nov 23, 2011119-day reviewClass III21 CFR 888.3330

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 Nov 23, 2011 as substantially equivalent to K100866 (Wrightmedicaltechnologyinc, 2010) and 6 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1994. 2 of the 28 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.

Decided: Nov 23, 2011
Review: 119 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 8

Its longest line of descent runs back 6 generations to K935452 (1994). 23 ancestors in all, the oldest K851422 (1985). 4 later devices descend from it, 2 citing it directly. 2 of the 28 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
5 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
4 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
3 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
2 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
1 generation backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
This deviceK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
Descendant · cites it directly · 1 of its ownK200007 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc. · 2020
Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Descendant · 2 generations on · 0 of its ownK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024

Class I recalls in this family

K100866 Profemur Hip System Modular Necksdirect predicate · 2010
K091423 Profemur Hip System Modular Necksdirect predicate · 2009

Most influential descendants

Showing 4 of 4 · See all

K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc. · 2020 · cites it directly1descendant
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
K250444NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025 · 2 generations on0descendants
K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K935452	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Orthopaedics, Inc.	1994	—
−5	K945518	P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
−4	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)	Johnson & Johnson Professionals, Inc.	1996	—
−3	K974331	Uni-Rom Total Hip System Femoral Stem	Johnson & Johnson Professionals, Inc.	1998	—
−2	K001991	Titan Porocoat Hip Prosthesis	DePuy Orthopaedics, Inc.	2000	—
−1	K042992	Corail Amt Hip Prosthesis	DePuy Orthopaedics, Inc.	2005	1
0 (this device)	K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	K200007	PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar	Microport Orthopedics, Inc.	2020	—
+1	K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	—
+2	K250444	NEXUS® Hip Stem	Microport Orthopedics, Inc.	2025	—
+2	K240452	Ceramic Femoral Head	Microport Orthopedics, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1989	1	0
1991	1	0
1992	2	0
1993	1	0
1994	2	0
1996	3	0
2001	1	0
2002	1	0
2006	1	0
2008	1	0
2009	1	1
2010	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2020	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K112150, 1994–2025Source: 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.

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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K100866	Profemur Hip System Modular Necks Summary page 1 …PROFEMUR6 Renaissance HA CORAILO Hip Prosthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Class…	Wrightmedicaltechnologyinc	2010	Class I
*	K091423	Profemur Hip System Modular Necks Summary page 1 …PROFEMUR6 Renaissance HA CORAILO Hip Prosthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification…	Wrightmedicaltechnologyinc	2009	Class I
*	K021346	Stem Hip Replacement System, Model PHA002XX Summary page 1 …EMUR6 Renaissance HA CORAILO Hip Prosthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification and Numb…	Wrightmedicaltechnologyinc	2002	3
*	K012091	Pro-Femur Summary page 1 …aissance HA CORAILO Hip Prosthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification and Number:…	Wrightmedicaltechnologyinc	2001	1
*	K060358	Profemur TL Hip Stem Summary page 1 …CORAILO Hip Prosthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A…	Wrightmedicaltechnologyinc	2006	—
Kept off the family tree	K105995	CORAIL Hip Prosthesis Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K953111	Corail Summary page 1 …sthesis 510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Descripti…	Landos, Inc.	1996	—
*	K042992	Corail Amt Hip Prosthesis Summary page 1 …510(k): K100866, K091423, K021346, K012091, K060358,K1(51995, K953111, K042992 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Description Th…	DePuy Orthopaedics, Inc.	2005	1

Also cleared against K100866: 3 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K200007	PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar	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)

No FDA recall names this device.

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 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
5 of the 23 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K200007 (Microport Orthopedics, Inc., 2020) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K100866.

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. 2011, 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?

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.

The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112150 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112150: Profemur Gladiator HA Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112150

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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