510(k) · Cleared
ClearedMedline ReNewal Reprocessed Synthes External Fixation Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 9, 2017 as substantially equivalent to K122455 (Synthes, 2013) and 2 other predicates after a 136-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Nov 9, 2017
- Review
- 136 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914558 (1992). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK914558 Traumafix (TM) External FixatorSynthes (Usa) · 1992
- 1 generation backK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
- This deviceK171911 Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914558 | Traumafix (TM) External Fixator | Synthes (Usa) | 1992 | — |
| −1 | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | Synthes | 2013 | 2 |
| 0 (this device) | K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | Surgical Instrument Service and Savings, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemSummary page 5…sories and smooth or threaded metallic bone fixation fastener. Regulation Number/Product Code: 888.3030/KTT Primary K122455 Synthes Small External Fixation System, Synthes Large External Predicate Fixation System Device Secondary Predi… | 2013 |
| * | K090658 | Synthes External Fixation Devices, MR ConditionalSummary page 5…y K122455 Synthes Small External Fixation System, Synthes Large External Predicate Fixation System Device Secondary Predicate 1 K090658 Synthes External Fixation Devices, MR conditional Device Secondary K092190 Synthes Distraction Osteogenesis Sys… | 2010 |
| * | K092190 | Synthes Distraction Osteogenesis System, MR Conditional with Expanded IndicationsSummary page 5…edicate Fixation System Device Secondary Predicate 1 K090658 Synthes External Fixation Devices, MR conditional Device Secondary K092190 Synthes Distraction Osteogenesis System, MR Conditional with Predicate 2 Expanded Indications Device… | 2010 |
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 25 years and passes through 3 companies; a new generation was cleared every 21.2 years on median.
- 8 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K122455.
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. 2017, 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?
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide 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…
Read the full statement (280 words)
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide 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 osteotomies
The Medline ReNewal Reprocessed Synthes Medium External Fixation System, MR Conditional is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Medline ReNewal Reprocessed Synthes Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
• Stabilization of soft tissues and fractures
• Polytrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a 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.
The Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171911: Medline ReNewal Reprocessed Synthes External Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171911
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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