510(k) · Cleared
Recalled · 2008Reprocessed External Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilemed, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 21, 2005 as substantially equivalent to K033158 (Synthes (Usa), 2003) and 2 other predicates after a 68-day review. Its family tree reaches back 1 generation to 2003. It has been recalled once.
- Decided
- Sep 21, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K031428 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031428 Synthes (Usa) Large External Fixation Clamps-MR SafeSynthes (Usa) · 2003 · Recalled
- This deviceK051957 Reprocessed External Fixation DeviceSterilemed, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031428 | Synthes (Usa) Large External Fixation Clamps-MR Safe | Synthes (Usa) | 2003 | 1 |
| 0 (this device) | K051957 | Reprocessed External Fixation Device | Sterilemed, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K033158 | Synthes Reprocessed External Fixation DevicesSummary page 1…l Fixation Device is substantially equivalent to the Synthes Reprocessed External Fixation Devices (K033158), Synthes Large External Fixation Clamps MR Safe (K031428) and Synthes Medium External… | 2003 |
| * | K031428 | Synthes (Usa) Large External Fixation Clamps-MR SafeSummary page 1…es Reprocessed External Fixation Devices (K033158), Synthes Large External Fixation Clamps MR Safe (K031428) and Synthes Medium External Fixation System MR Safe (K040258). Device Description:… | 2003 |
| * | K040258 | Synthes Medium External Fixation System-MR SafeSummary page 1…rge External Fixation Clamps MR Safe (K031428) and Synthes Medium External Fixation System MR Safe (K040258). Device Description: The Reprocessed External Fixation Device consists of the… | 2004 |
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 |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0556-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K033158.
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 Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. LARGE Provide treatment for long bone and pelvic fractures that require external fixation Specifically, the components are used for: * Stabilization of soft tissues and fractures * Polytrauma/multiple orthopedic trauma * Vertically stable pelvic fractures, or as treatment…
Read the full statement (276 words)
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE
Provide treatment for long bone and pelvic fractures that require external fixation
Specifically, the components are used for:
* Stabilization of soft tissues and fractures
* Polytrauma/multiple orthopedic trauma
* Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures
* Arthrodeses and osteotomies with soft tissue problems; failures of total joints
* Neutralization of fractures stabilized with limited internal fixation
* Non-unions/septic non-unions
* Intra-operative reductions/stabilization tool to assist with indirect reduction
* Unilateral rectilinear bone segment transport or leg lengthening
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL
Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, forearm, foot and ankle. Specifically, the components can be used for:
* Preliminary fixation before ORIF
* Unstable fractures of the distal radius (both intra and extra-articular)
* Open and/or comminuted bilateral fractures
* Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
* Fracture dislocations
* Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
* Pediatric open fractures with bone loss and osteotomy
MINI
Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for:
* Comminuted fractures of phalanges and metacarpals
* Displaced intra-articular fractures
* Segmental bone loss
* Open fractures that do not allow stable internal fixation
* Fractures with associated complex soft tissue injuries
* Tumor resections
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051957 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051957: Reprocessed External Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051957
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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