510(k) · Cleared
ClearedLima-Lto. Sem Modular External Stablizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima-Lto, Inc. · JEC Component, Traction, Invasive
Cleared on Feb 18, 1988 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 135 later devices descend from it.
- Decided
- Feb 18, 1988
- Review
- 28 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 0
135 later devices descend from it, 2 citing it directly.
- This deviceK880282 Lima-Lto. Sem Modular External StablizerLima-Lto, Inc. · 1988
- Descendant · cites it directly · 133 of its ownK964094 MinifixFerguson Medical · 1996
- Descendant · 2 generations on · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- Descendant · 3 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K964094MinifixFerguson Medical · 1996 · cites it directly133descendants
- K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · 2 generations on120descendants
- K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 3 generations on91descendants
- K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · 3 generations on46descendants
- K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · 3 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880282 | Lima-Lto. Sem Modular External Stablizer | Lima-Lto, Inc. | 1988 | — |
| +1 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| +2 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| +3 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| +3 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100933 | Consensus CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (135)
See all 1352 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?
- Of its descendants, K964094 (Ferguson Medical, 1996) has gone furthest, with 133 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K880282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880282: Lima-Lto. Sem Modular External Stablizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880282
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026