510(k) · Cleared
ClearedReprocessed External Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Feb 3, 2003 as substantially equivalent to K802814 (Cintor Orthopaedic Div., 1980) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Feb 3, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K831576 (1983). 4 ancestors in all, the oldest K802814 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- This deviceK023714 Reprocessed External Fixation DeviceAlliance Medical Corp. · 2003
- Descendant · cites it directly · 0 of its ownK052065 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K052065Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| 0 (this device) | K023714 | Reprocessed External Fixation Device | Alliance Medical Corp. | 2003 | — |
| +1 | K052065 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 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 21.4 · 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? (4)
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 |
|---|---|---|---|
| * | K802814 | Orthofix Axialexternal Fixation Sys.Summary page 1…Fastener Predicate device(s): Legally marketed external fixation devices under various .51O(k) premarket notifications. K802814 Orthofix@Axial External Fixation System K831576 Orthofix@ K944092… | 1980 |
| * | K831576 | OrthofixSummary page 1…nder various .51O(k) premarket notifications. K802814 Orthofix@Axial External Fixation System K831576 Orthofix@ K944092 Additional Accessories for the OrthofixB System K9558… | 1983 |
| * | K944092 | Additional Accessories for the Orthofix SystemSummary page 1…market notifications. K802814 Orthofix@Axial External Fixation System K831576 Orthofix@ K944092 Additional Accessories for the OrthofixB System K955848 OrthofixB Modulsystem Device descript… | 1995 |
| * | K955848 | Orthofix ModulsystemSummary page 1…ixation System K831576 Orthofix@ K944092 Additional Accessories for the OrthofixB System K955848 OrthofixB Modulsystem Device description: External fixation devices are specially designed frames, clamps,… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052065 | Alliance Medical Corporation Reprocessed External Fixation Devices | 2005 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052065 (Alliance Medical Corp., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K802814.
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?
Reprocessed external. fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023714 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023714: Reprocessed External Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023714
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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