510(k) · Cleared
Recalled · 2012Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Mar 6, 2009 after a 156-day review. The FDA summary names no predicate by number. 25 later devices descend from it. It has been recalled 17 times.
- Decided
- Mar 6, 2009
- Review
- 156 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 17
- Predicates
- 0
25 later devices descend from it, 9 citing it directly.
- This deviceK082924 Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular…Wrightmedicaltechnologyinc · 2009
- Descendant · cites it directly · 16 of its ownK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- Descendant · cites it directly · 10 of its ownK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · cites it directly · 5 of its ownK122382 Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · 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
- K122382Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012 · cites it directly5descendants
- K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner… | Wrightmedicaltechnologyinc | 2009 | — |
| +1 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| +1 | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +1 | K122382 | Dynasty Biofoam Shell | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K111910 | Gladiator Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (25)
See all 259 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170444 | PROCOTYL® PRIME Acetabular Cup System | 2017 | 16 |
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | 2017 | 10 |
| K122382 | Dynasty Biofoam Shell | 2012 | 5 |
| K111910 | Gladiator Hip Stem | 2011 | 5 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | 2018 | 1 |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | 2021 | 0 |
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | 2021 | 0 |
| K121544 | Dynasty Biofoam Shell | 2012 | 0 |
| K110029 | Conserve Bio Foam Shell | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2012 | Not classified | Z-1022-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1017-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1020-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1021-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1026-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1027-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1018-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1019-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1016-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1023-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1024-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1025-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1028-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1029-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1030-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jan 3, 2012 | Not classified | Z-1031-2012 | Packaging | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
| Jun 7, 2010 | Not classified | Z-2212-2010 | Software design (manufacturing process) | The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method. |
The 5 latest of 17 recalls; the web page lists all.
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 KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 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 DYNASTY® 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…
Read the full statement (111 words)
The DYNASTY® 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 size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or
malunion of the acetabulum, and/or revision.
The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use
device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082924
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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