510(k) · Cleared

Cleared

Gladiator Hip Stem

K111910510(k) TraditionalCleared Oct 14, 2011101-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 Oct 14, 2011 as substantially equivalent to K100866 (Wrightmedicaltechnologyinc, 2010) and 8 other predicates after a 101-day review. Its family tree reaches back 6 generations to 1994. 2 of the 31 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.

Decided: Oct 14, 2011
Review: 101 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 9

Its longest line of descent runs back 6 generations to K935452 (1994). 25 ancestors in all, the oldest K851422 (1985). 5 later devices descend from it, 3 citing it directly. 2 of the 31 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 deviceK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
Descendant · cites it directly · 1 of its ownK201519 PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. · 2020
Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
Descendant · cites it directly · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Descendant · 2 generations on · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Descendant · 2 generations on · 0 of its ownK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022

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 5 of 5 · See all

K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. · 2020 · cites it directly1descendant
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · cites it directly0descendants
K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · 2 generations on0descendants
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022 · 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)	K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	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	K240046	Ethylene Oxide Sterilization Supplier Change for MPO Hips	Microport Orthopedics	2024	—
+2	K240452	Ceramic Femoral Head	Microport Orthopedics, Inc.	2024	—
+2	K213816	MPO Hip Instruments	Microport Orthopedics, Inc.	2022	—

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	2	0
2008	1	0
2009	2	1
2010	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2020	1	0
2022	1	0
2024	2	0

FIG. 1 — Lineage of K111910, 1994–2024Source: 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.

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? (9)

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
*	K100866	Profemur Hip System Modular Necks Summary page 1 …RAIL® Hip Prosthesis DYNASTY® BIOFOAM' m Acetabular System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924…	Wrightmedicaltechnologyinc	2010	Class I
*	K091423	Profemur Hip System Modular Necks Summary page 1 …Prosthesis DYNASTY® BIOFOAM' m Acetabular System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicat…	Wrightmedicaltechnologyinc	2009	Class I
*	K021346	Stem Hip Replacement System, Model PHA002XX Summary page 1 …DYNASTY® BIOFOAM' m Acetabular System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classifi…	Wrightmedicaltechnologyinc	2002	3
*	K012091	Pro-Femur Summary page 1 …DYNASTY® BIOFOAM' m Acetabular System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and…	Wrightmedicaltechnologyinc	2001	1
*	K052915	Profemur XTR Hip Stem Summary page 1 …Acetabular System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE…	Wrightmedicaltechnologyinc	2006	3
*	K060358	Profemur TL Hip Stem Summary page 1 …r System 510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATIO…	Wrightmedicaltechnologyinc	2006	—
*	K953111	Corail Summary page 1 …510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Devic…	Landos, Inc.	1996	—
*	K042992	Corail Amt Hip Prosthesis Summary page 1 …510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Descript…	DePuy Orthopaedics, Inc.	2005	1
*	K082924	Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal… Summary page 1 …510(k): K(100866, K(091423, K(021346, K(012091, K(052915, K(060358, K(953111, K(042992, K(082924 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Description Th…	Wrightmedicaltechnologyinc	2009	17

Also cleared against K100866: 3 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
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
K240046	Ethylene Oxide Sterilization Supplier Change for MPO Hips	Microport Orthopedics	2024	0

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.
7 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K201519 (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 Inecrosis, ankylosis, protrusio acetabuli, and painful hip dlysplasia;

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 Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty.

The Gladiator Cemented hip stem is intended for cemented hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111910 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111910: Gladiator 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/K111910

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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