510(k) · Cleared

Cleared

Gladiator Plasma Classic Hip Stem

K110399510(k) TraditionalCleared May 10, 201188-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 May 10, 2011 as substantially equivalent to K021346 (Wrightmedicaltechnologyinc, 2002) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: May 10, 2011
Review: 88 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K004043 (2001). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
This deviceK110399 Gladiator Plasma Classic Hip StemWrightmedicaltechnologyinc · 2011
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 ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024

Most influential descendants

Showing 2 of 2 · See all

K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
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
−1	K004043	Metal Transcend Articulation System	Wrightmedicaltechnologyinc	2001	—
0 (this device)	K110399	Gladiator Plasma Classic Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	—
+2	K240452	Ceramic Femoral Head	Microport Orthopedics, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2006	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K110399, 2001–2024Source: 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 KWA? 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? (4)

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
*	K021346	Stem Hip Replacement System, Model PHA002XX Summary page 1 …duct Code and Panel Code: KWA, JDL, LZO. Orthopedics/87. (a)(3) Predicate Device Predicate Proprietary Name: STEM Hlip Replacement System - K02 1346. PRO-FEMUR Hip System - K012091. Me…	Wrightmedicaltechnologyinc	2002	3
*	K012091	Pro-Femur Summary page 1 …cate Device Predicate Proprietary Name: STEM Hlip Replacement System - K02 1346. PRO-FEMUR Hip System - K012091. Metal TRANSCEND Articulation System-…	Wrightmedicaltechnologyinc	2001	1
*	K004043	Metal Transcend Articulation System Summary page 1 …PRO-FEMUR Hip System - K012091. Metal TRANSCEND Articulation System- K004043. PROFEMUR TL Hip Stem - K060358 Predicate Classification and Number: Cl…	Wrightmedicaltechnologyinc	2001	—
*	K060358	Profemur TL Hip Stem Summary page 1 …Metal TRANSCEND Articulation System- K004043. PROFEMUR TL Hip Stem - K060358 Predicate Classification and Number: Class III - Hip joint metal/ceramic/polymer…	Wrightmedicaltechnologyinc	2006	—

Also cleared against K021346: 10 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	1

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?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K173898 (Microport Orthopedics Inc. (Mpo), 2018) has gone furthest, with 1 descendant of its own.
10 other devices also cite its predicate K021346.

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?

The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

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

GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110399 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110399: Gladiator Plasma Classic 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/K110399

Report an extraction error

Are you the manufacturer?

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