510(k) · Cleared

Cleared

Dynasty Acetabular System with Ceramic

K130376510(k) TraditionalCleared Jul 3, 2013139-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 3, 2013 as substantially equivalent to K072656 (Wrightmedicaltechnologyinc, 2008) after a 139-day review. Its family tree reaches back 1 generation to 2008. 12 later devices descend from it.

Decided: Jul 3, 2013
Review: 139 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K072656 (2008). 12 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK072656 Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc · 2008
This deviceK130376 Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013
Descendant · cites it directly · 10 of its ownK140043 Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta…Microport Orthopedics, Inc. · 2014
Descendant · cites it directly · 9 of its ownK142119 Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc. · 2015
Descendant · 2 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
Descendant · 3 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
Descendant · cites it directly · 2 of its ownK173776 BIOLOX delta Option and Extra-long HeadsMicroport Orthopedics, Inc. · 2018

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2014high 3 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all

K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc. · 2014 · cites it directly10descendants
K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc. · 2015 · cites it directly9descendants
K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 2 generations on5descendants
K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
K173776BIOLOX delta Option and Extra-long HeadsMicroport Orthopedics, Inc. · 2018 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K072656	Dynasty Ceramic Femoral Head	Wrightmedicaltechnologyinc	2008	—
0 (this device)	K130376	Dynasty Acetabular System with Ceramic	Wrightmedicaltechnologyinc	2013	—
+1	K140043	Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head	Microport Orthopedics, Inc.	2014	—
+1	K142119	Procotyl L-O Acetabular System	Microport Orthopedics, Inc.	2015	—
+2	K180263	EcoFit Vit E Acetabular System	Implantcast GmbH	2018	—
+3	K203420	EcoFit® Hip System	Implantcast GmbH	2021	—
+1	K173776	BIOLOX delta Option and Extra-long Heads	Microport Orthopedics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2018	3	0
2021	1	0
2023	1	0
2024	3	0
2026	2	0

FIG. 1 — Lineage of K130376, 2008–2026Source: 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 LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K072656	Dynasty Ceramic Femoral Head Summary page 1 …Orthopedics/87/LZO Predicate Devices: DYNASTY® Acetabular System 5 10(k)s: K072656 DEVICE INFORMATION A. Intended Use Wright Medical total hip systems are indicated for use in total hip arthroplasty for re…	Wrightmedicaltechnologyinc	2008	—
†	K052026	Lineage a-Class Poly Liner	Wrightmedicaltechnologyinc	2005	—
†	K091423	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2009	Class I
†	K100866	Profemur Hip System Modular Necks	Wrightmedicaltechnologyinc	2010	Class I

Also cleared against K072656: 3 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K140043	Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head	Microport Orthopedics, Inc.	2014	10
K142119	Procotyl L-O Acetabular System	Microport Orthopedics, Inc.	2015	9
K173776	BIOLOX delta Option and Extra-long Heads	Microport Orthopedics, Inc.	2018	2
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?

Its one ancestor has no recall.
Of its descendants, K140043 (Microport Orthopedics, Inc., 2014) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K072656.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

Wright Medical total hip systems are 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/K130376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130376: Dynasty Acetabular System with Ceramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130376

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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