510(k) · Cleared
ClearedDynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 3, 2014 as substantially equivalent to K130376 (Wrightmedicaltechnologyinc, 2013) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 2008. 10 later devices descend from it.
- Decided
- Apr 3, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K072656 (2008). 4 ancestors in all, the oldest K002149 (2000). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK072656 Dynasty Ceramic Femoral HeadWrightmedicaltechnologyinc · 2008
- 1 generation backK130376 Dynasty Acetabular System with CeramicWrightmedicaltechnologyinc · 2013
- This deviceK140043 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 · 3 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
- Descendant · 3 generations on · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 3 generations on1descendant
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072656 | Dynasty Ceramic Femoral Head | Wrightmedicaltechnologyinc | 2008 | — |
| −1 | K130376 | Dynasty Acetabular System with Ceramic | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | 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 | — |
| +3 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
| +3 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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 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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K130376 | Dynasty Acetabular System with CeramicSummary page 1…Orthopedics/87/LZO Predicate Devices: DYNASTY® Acetabular System with Ceramic 510(k): K130376 Shell: K002149; Liner: K(052026; Head: K130376 DEVICE INFORMATION A. Intended… | 2013 |
| * | K002149 | Lineage Acetabular SystemSummary page 1…DYNASTY® Acetabular System with Ceramic 510(k): K130376 Shell: K002149; Liner: K(052026; Head: K130376 DEVICE INFORMATION A. Intended Use MicroPort total hip systems are indicated for use in total… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 2…eatures of the subject acetabular liner and shell devices are substantially equivalent to those of the predicate LINEAGE® Acetabular system devices cleared under K052026 and K002 149. The indications of the subject device are identical to the predicate. Specific warnings are added in the packag… | 2005 |
| † | K091423 | Profemur Hip System Modular Necks | 2009 |
| † | K100866 | Profemur Hip System Modular Necks | 2010 |
| † | K893685 | Ceramic Femoral Head | 1989 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142119 (Microport Orthopedics, Inc., 2015) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K130376.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 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?
The DYNASTYS Acetabular System is intended for use in total hip erthroplasty for reduction or relief of pain andor improved hip function in skeletally matulre patients. 1. non-inflammuratory degenerativejoint disease such as osteoarthrfids, evascular necrosis, ankylosis, proflusio acetabuli, and painfful hip dysplasia. 2. inflammatory degenerativejoint disease such as rheumatoid arthritis; 3. correction of fuznctional deformnity; and, 4. revision…
Read the full statement (94 words)
The DYNASTYS Acetabular System is intended for use in total hip erthroplasty for reduction or relief of pain andor improved hip function in skeletally matulre patients.
1. non-inflammuratory degenerativejoint disease such as osteoarthrfids, evascular necrosis, ankylosis, proflusio acetabuli, and painfful hip dysplasia.
2. inflammatory degenerativejoint disease such as rheumatoid arthritis;
3. correction of fuznctional deformnity; and,
4. revision procedures where other treatments or devices have faled
Shells with BIOFOAMW) metal foam coating are intended only for u=cemnented arthmoplasty. Modular shells with porous metal bead coating may be used in either cemented or uncemented artliroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140043: Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140043
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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