510(k) · Cleared

Cleared

Conserve Thin Shell

K113322510(k) SpecialCleared Feb 3, 201285-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 Feb 3, 2012 as substantially equivalent to K042530 (Wrightmedicaltechnologyinc, 2004) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 3, 2012
Review: 85 days
Class: Class III
Product code: KWA
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K004043 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK004043 Metal Transcend Articulation SystemWrightmedicaltechnologyinc · 2001
1 generation backK021349 Metal Transcend Articulation System (Larger Sizes)Wrightmedicaltechnologyinc · 2002
This deviceK113322 Conserve Thin ShellWrightmedicaltechnologyinc · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K004043	Metal Transcend Articulation System	Wrightmedicaltechnologyinc	2001	—
−1	K021349	Metal Transcend Articulation System (Larger Sizes)	Wrightmedicaltechnologyinc	2002	—
0 (this device)	K113322	Conserve Thin Shell	Wrightmedicaltechnologyinc	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K113322, 2001–2012Source: 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? (2)

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
*	K042530	Conserve Plus HA Acetabular Shells Summary page 1 …Shell (cleared as "Metal TRANSCENDS Articulation System") 510(k)s: K042530, K021349 DEVICE INFORMATION A. Intended Use The CONSERVE® Thin Shells are intended for use in cementless total hip arthropla…	Wrightmedicaltechnologyinc	2004	—
*	K021349	Metal Transcend Articulation System (Larger Sizes) Summary page 1 …eared as "Metal TRANSCENDS Articulation System") 510(k)s: K042530, K021349 DEVICE INFORMATION A. Intended Use The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for r…	Wrightmedicaltechnologyinc	2002	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 9.6 years on median.
None of the 3 ancestors has a recall.

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. 2012, 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 CONSERVE® Thin Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusia 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 CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113322 · printed Nov 5, 2026

Cite this page

510(k) Report. “K113322: Conserve Thin Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113322

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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