510(k) · Cleared
ClearedMinifix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferguson Medical · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 27, 1996 as substantially equivalent to K861766 (Howmedica Corp., 1986) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1986. 133 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 47 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861766 (1986). 2 ancestors in all. 133 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- This deviceK964094 MinifixFerguson Medical · 1996
- Descendant · cites it directly · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
- Descendant · 3 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · cites it directly120descendants
- K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 2 generations on91descendants
- K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · 2 generations on46descendants
- K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · 2 generations on35descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| 0 (this device) | K964094 | Minifix | Ferguson Medical | 1996 | — |
| +1 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| +2 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| +2 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +2 | K100933 | Consensus CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 2010 | — |
| +3 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 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), 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K861766 | Howmedica Hoffmann Fixation Pin SystemSummary page 1…readed. Common/usual name: Unilateral mini-fixator, finger fixator, etc. Proprietary name: MINIFIX B. Substantial equivalence: Howmedica Hoffmann Fixation Pin System (K861766), Lima-LTO SEM Modular External Stabilizer (K880282) and others. C. Device description: The MINIFIX is a unilateral external fix… | 1986 |
| * | K880282 | Lima-Lto. Sem Modular External StablizerSummary page 1…finger fixator, etc. Proprietary name: MINIFIX B. Substantial equivalence: Howmedica Hoffmann Fixation Pin System (K861766), Lima-LTO SEM Modular External Stabilizer (K880282) and others. C. Device description: The MINIFIX is a unilateral external fixator designed for use on small bones such as the met… | 1988 |
What descends from it? (133)
See all 1334 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 KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The MINIFIX is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
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/K964094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964094: Minifix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964094
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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