510(k) Report

510(k) · Cleared

Cleared

Dynasty Ceramic Femoral Head

K072656510(k) SpecialCleared Feb 6, 2008139-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 Feb 6, 2008 after a 139-day review. The FDA summary names no predicate by number. 13 later devices descend from it.

Decided
Feb 6, 2008
Review
139 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

13 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2018: 3 descendants cleared2024: 3 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2026: 2 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK072656 Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc · 2008
  2. Descendant · cites it directly · 12 of its ownK130376 Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013
  3. Descendant · 2 generations on · 10 of its ownK140043 Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta…Microport Orthopedics, Inc. · 2014
  4. Descendant · 2 generations on · 9 of its ownK142119 Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc. · 2015
  5. Descendant · 3 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  6. Descendant · 4 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12018: 32021: 12023: 12024: 32026: 2
2013high 3 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all
  • K130376Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013 · cites it directly12descendants
  • K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc. · 2014 · 2 generations on10descendants
  • K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc. · 2015 · 2 generations on9descendants
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 3 generations on5descendants
  • K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072656Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc2008—
+1K130376Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc2013—
+2K140043Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadMicroport Orthopedics, Inc.2014—
+2K142119Procotyl L-O Acetabular SystemMicroport Orthopedics, Inc.2015—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH2018—
+4K203420EcoFit® Hip SystemImplantcast GmbH2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201830
202110
202310
202430
202620
FIG. 1 — Lineage of K072656, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K130376Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc201312
K173776BIOLOX delta Option and Extra-long HeadsMicroport Orthopedics, Inc.20182
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240

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?

  • Of its descendants, K130376 (Wrightmedicaltechnologyinc, 2013) has gone furthest, with 12 descendants of its own.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
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

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The DYNASTY TM Acetabular System is 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

The DYNASTY TM Acetabular Shell is for both cemented and uncemented use.

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K072656 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072656: Dynasty Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072656

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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