510(k) · Cleared

Cleared

Metal Transcend Articulation System (Larger Sizes)

K021349510(k) AbbreviatedCleared Jul 1, 200263-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 Jul 1, 2002 as substantially equivalent to K004043 (Wrightmedicaltechnologyinc, 2001) after a 63-day review. Its family tree reaches back 1 generation to 2001. 125 later devices descend from it.

Decided: Jul 1, 2002
Review: 63 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K004043 (2001). 125 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
This deviceK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
Descendant · cites it directly · 116 of its ownK042037 M2A Magnum SystemBiomet, Inc. · 2004
Descendant · cites it directly · 74 of its ownK053536 Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · Recalled
Descendant · 2 generations on · 73 of its ownK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
Descendant · 3 generations on · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
Descendant · 3 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

2004high 14 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 125 · See all

K042037M2A Magnum SystemBiomet, Inc. · 2004 · cites it directly116descendants
K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH · 2006 · cites it directly74descendants
K071723Zimmer Porolock Mis StemZimmer GmbH · 2008 · 2 generations on73descendants
K123392Avenir Muller StemZimmer GmbH · 2013 · 3 generations on41descendants
K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 3 generations on34descendants

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)	K021349	Metal Transcend Articulation System (Larger Sizes)	Wrightmedicaltechnologyinc	2002	—
+1	K042037	M2A Magnum System	Biomet, Inc.	2004	—
+1	K053536	Durom Acetabular Component and Metasul LDH Large Diameter Heads	Zimmer GmbH	2006	13
+2	K071723	Zimmer Porolock Mis Stem	Zimmer GmbH	2008	2
+3	K123392	Avenir Muller Stem	Zimmer GmbH	2013	4
+3	K110400	Taperloc Complete Microplasty Stem	Biomet Manufacturing Corp	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	5	0
2007	1	0
2008	4	0
2009	2	0
2011	3	0
2012	5	0
2013	5	0
2014	5	0
2015	6	0
2016	7	0
2017	6	0
2018	8	0
2019	14	0
2020	12	0
2021	8	0
2022	3	0
2023	5	0
2024	8	0
2025	7	0
2026	9	0

FIG. 1 — Lineage of K021349, 2001–2026Source: 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.

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

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What was it cleared against? (1)

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
*	K004043	Metal Transcend Articulation System Summary page 2 …e for single use only. B. DEVICE DESCRIPTION The previously submitted and cleared Metal TRANSCEND@Articulation System (Exhibit 1: 510(k) K004043) is composed of two pieces, a metal shell and a metal liner that mates to the shell by the use of a taper locking mec…	Wrightmedicaltechnologyinc	2001	—

Also cleared against K004043: 3 other devices →

What descends from it? (125)

See all 125

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

Number	Device	Applicant	Decided	Descendants
K042037	M2A Magnum System	Biomet, Inc.	2004	116
K053536	Durom Acetabular Component and Metasul LDH Large Diameter Heads	Zimmer GmbH	2006	74
K040627	Depuy Asr Modular Acetabular Cup System	DePuy Orthopaedics, Inc.	2005	9
K113322	Conserve Thin Shell	Wrightmedicaltechnologyinc	2012	0
K110029	Conserve Bio Foam Shell	Wrightmedicaltechnologyinc	2011	0
K080991	Depuy Asr XL Modular Acetabular Cup System	DePuy Orthopaedics, Inc.	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K042037 (Biomet, Inc., 2004) has gone furthest, with 116 descendants of its own.
3 other devices also cite its predicate K004043.

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.

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?

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-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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021349 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021349: Metal Transcend Articulation System (Larger Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021349

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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