510(k) · Cleared
ClearedDynasty Biofoam Shell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Cleared on Oct 22, 2012 as substantially equivalent to K082924 (Wrightmedicaltechnologyinc, 2009) after a 77-day review. Its family tree reaches back 1 generation to 2009. 5 later devices descend from it.
- Decided
- Oct 22, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082924 (2009). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK082924 Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular…Wrightmedicaltechnologyinc · 2009 · Recalled
- This deviceK122382 Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
- Descendant · cites it directly · 2 of its ownK170288 BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM®…Microport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK201157 Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK202705 Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION®…Microport Orthopedics, Inc. · 2017 · cites it directly2descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 2 generations on1descendant
- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc. · 2021 · cites it directly0descendants
- K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner… | Wrightmedicaltechnologyinc | 2009 | 17 |
| 0 (this device) | K122382 | Dynasty Biofoam Shell | Wrightmedicaltechnologyinc | 2012 | — |
| +1 | K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base… | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +3 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
| +1 | K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021 | — |
| +1 | K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 MBL? 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 MBL device
- #1 K201157 Prime BIOFOAM® Multi-Hole Shellsscore 3.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…Summary page 1…opedics/87/ LZO, MBL, JDI Predicate Devices: DYNASTY® Acetabular System 5 l0(k)s: K082924 DEVICE INFORMNATION A. Intended Use The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty f… | 2009 |
| † | K121544 | Dynasty Biofoam Shell | 2012 |
What descends from it? (5)
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?
How does its category compare?
All MBL devicesMBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MBL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MBL
Too few MBL 510(k)s in any year since 2007 to give a median.
Recalls per year · MBL
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBL
41in 2025
MAUDE reports naming product code MBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 6 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 1 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 1 | — | 0 | 112 |
| 2019 | 0 | — | 0 | 172 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 1 | — | 0 | 116 |
| 2022 | 0 | — | 0 | 90 |
| 2023 | 0 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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® BIOFOAM®)Shell is intended for cementless hip arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122382: Dynasty Biofoam Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122382
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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