510(k) Report

510(k) · Cleared

Cleared

Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner

K061547510(k) SpecialCleared Jul 3, 200628-day reviewClass II21 CFR 888.3358

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

Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 3, 2006 after a 28-day review. The FDA summary names no predicate by number. 17 later devices descend from it.

Decided
Jul 3, 2006
Review
28 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2024: 3 descendants cleared2017: 2 descendants cleared2018: 4 descendants cleared2022: 1 descendant cleared2021: 3 descendants cleared2019: 1 descendant cleared2026: 2 descendants cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK061547 Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerWrightmedicaltechnologyinc · 2006
  2. Descendant · cites it directly · 16 of its ownK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
  3. Descendant · cites it directly · 10 of its ownK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
  4. Descendant · 2 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  5. Descendant · 3 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
  6. Descendant · 2 generations on · 2 of its ownK180798 Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2017: 22018: 42019: 12021: 32022: 12023: 12024: 32026: 2
2017high 4 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 17 · See all
  • K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017 · cites it directly16descendants
  • K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017 · cites it directly10descendants
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 2 generations on5descendants
  • K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
  • K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061547Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerWrightmedicaltechnologyinc2006—
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.2017—
+1K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.2017—
+2K180263EcoFit Vit E Acetabular SystemImplantcast GmbH2018—
+3K203420EcoFit® Hip SystemImplantcast GmbH2021—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201840
201910
202130
202210
202310
202430
202620
FIG. 1 — Lineage of K061547, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716
K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.201710
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, K170444 (Microport Orthopedics, Inc., 2017) has gone furthest, with 16 descendants of its own.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The DYNASTYVM 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

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • 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 LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K061547 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061547: Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061547

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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