510(k) · Cleared
Recalled · Class II · 2014Reflection Dual Dimension Shell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Cleared on Mar 27, 1996 after a 76-day review. The FDA summary names its predicate without a number. 18 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- MBL
- Recalls
- 1
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK960094 Reflection Dual Dimension ShellSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 12 of its ownK112898 Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 10 of its ownK141395 Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 3 of its ownK182099 Delta TT ProLima Corporate S.P.A. · 2018
- Descendant · 3 generations on · 2 of its ownK191622 Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly12descendants
- K141395Delta TT Acetabular SystemLima Corporate S.P.A. · 2014 · 2 generations on10descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K182099Delta TT ProLima Corporate S.P.A. · 2018 · 2 generations on3descendants
- K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960094 | Reflection Dual Dimension Shell | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K112898 | Delta TT Cups, Delta TT Liners, Bone Screws | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141395 | Delta TT Acetabular System | Lima Corporate S.P.A. | 2014 | 1 |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018 | — |
| +3 | K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | — | Osteonics PSL Named without a submission number | |
| * | — | DePuy Duraloc Named without a submission number |
What descends from it? (18)
See all 183 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2014 | Class II | Z-1066-2014 | Under Investigation by firm | Inner spherical radius of the shell is undersized. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112898 (Lima Corporate S.P.A., 2012) has gone furthest, with 12 descendants of its own.
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.
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?
The indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960094: Reflection Dual Dimension Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960094
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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