510(k) · Cleared
ClearedTempfix External Fixation System, MR Safe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 21, 2005 as substantially equivalent to K021933 (DePuy Orthopaedics, Inc., 2002) and 2 other predicates after a 72-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jan 21, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K875022 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875022 | Ace/Fisher Percutaneous Transfixing Pins | Buckman Co., Inc. | 1988 | — |
| −1 | K021933 | Tempfix External Fixation System | DePuy Orthopaedics, Inc. | 2002 | — |
| 0 (this device) | K043113 | Tempfix External Fixation System, MR Safe | DePuy Orthopaedics, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K021933 | Tempfix External Fixation SystemSummary page 1…cessories Device Product Codes: 87 KTT Substantially Equivalent Devices: TempFixTm External Fixation System (predicate device) K02 1933 Synthes Medium External Fixation System (for MR safety) KOI 1034 E131® DynaFix®Vision Tm External Fixation Syst… | 2002 |
| * | K011034 | Synthes (Usa) Medium External Fixation System | 2001 |
| * | K961433 | Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone ScrewsSummary page 1…K02 1933 Synthes Medium External Fixation System (for MR safety) KOI 1034 E131® DynaFix®Vision Tm External Fixation System (for MR safety) K96 1433 Device Description: The TempFix External Fixation System consists of components that can be assembled to provide multiple degree… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K021933.
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 TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.
When used without adjunctive support, the TempFix External Fixation System is intended to be non-weight bearing.
The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043113: Tempfix External Fixation System, MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043113
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