510(k) · Cleared
ClearedSynthes Combination Clamp and Dynamization Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 16, 1997 after a 64-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 16, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973017 Synthes Combination Clamp and Dynamization ClipSynthes (Usa) · 1997
- Descendant · cites it directly · 0 of its ownK122208 External Fixator SystemChristopher D. Endara · 2012
Most influential descendants
Showing 1 of 1 · See all- K122208External Fixator SystemChristopher D. Endara · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973017 | Synthes Combination Clamp and Dynamization Clip | Synthes (Usa) | 1997 | — |
| +1 | K122208 | External Fixator System | Christopher D. Endara | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 21.3 · 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? (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 |
|---|---|---|---|
| * | — | Synthes Adjustable Clamp Named without a submission number |
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 |
|---|---|---|---|
| K122208 | External Fixator System | 2012 | 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?
- Of its descendants, K122208 (Christopher D. Endara, 2012) has gone furthest, with 0 descendants of its own.
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 Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: stabilization of soft tissue injuries and open or closed fractures; polytrauma; vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; arthrodesis…
Read the full statement (101 words)
The Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:
stabilization of soft tissue injuries and open or closed fractures;
polytrauma;
vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
arthrodesis and osteotomies with soft tissue problems;
failures of total joints;
neutralization of fractures stabilized with limited internal fixation;
non-unions/septic non-unions;
intraoperative reduction/stabilization tool to assist with indirect reduction;
unilateral rectilinear bone segment transport or leg lengthening;
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/K973017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973017: Synthes Combination Clamp and Dynamization Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973017
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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