510(k) · Cleared
Recalled · Class II · 2016Integra External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jul 6, 2016 as substantially equivalent to K140463 (Ascension Orthopedic, 2014) after a 103-day review. Its family tree reaches back 4 generations to 1989. It has been recalled 2 times.
- Decided
- Jul 6, 2016
- Review
- 103 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890814 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890814 Danek Ring Fixator (DRF)Danek Medical, Inc. · 1989
- 3 generations backK071394 Modification to:Sbi RingfixSmall Bone Innovations, Inc. · 2007 · Recalled
- 2 generations backK093057 Biomet Vision Footring SystemEbi, L.P. · 2009
- 1 generation backK140463 Integra External Fixation SystemAscension Orthopedic · 2014 · Recalled
- This deviceK160830 Integra External Fixation SystemAscension Orthopedics · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890814 | Danek Ring Fixator (DRF) | Danek Medical, Inc. | 1989 | — |
| −3 | K071394 | Modification to:Sbi Ringfix | Small Bone Innovations, Inc. | 2007 | 1 |
| −2 | K093057 | Biomet Vision Footring System | Ebi, L.P. | 2009 | — |
| −1 | K140463 | Integra External Fixation System | Ascension Orthopedic | 2014 | 3 |
| 0 (this device) | K160830 | Integra External Fixation System | Ascension Orthopedics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K140463 | Integra External Fixation SystemSummary page 6…: The performance of the Integra® External Fixation System was verified to be statistically equivalent to that of the predicate device (Integra External Fixation System, K140463). The K160830 - Page 4 of 4 Integra LifeSciences Corporation Special 51… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2016 | Class II | Z-2387-2016 | Device Design | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. |
| Jul 20, 2016 | Class II | Z-2386-2016 | Device Design | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K140463.
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. 2016, this device’s year, is highlighted.
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 Integra® External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
* Correction of deformity
* Revision procedures where other treatments or devices have been unsuccessful
* Bone reconstruction procedures
* Fusions and replantations of the foot
* Charcot reconstruction and Lisfranc dislocations
* Ankle distraction (arthrodiastasis)
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/K160830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160830: Integra External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160830
Report an extraction error
Are you the manufacturer?
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