510(k) · Cleared
ClearedSynthes Large Fragment Dynamic Compression Locking (DCL) System
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 May 1, 2000 after a 62-day review. The FDA summary names its predicate without a number. 340 later devices descend from it.
- Decided
- May 1, 2000
- Review
- 62 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
340 later devices descend from it, 25 citing it directly.
- This deviceK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- Descendant · cites it directly · 186 of its ownK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 51 of its ownK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- Descendant · 2 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Showing 5 of 340 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 340 · See all- K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa) · 2008 · cites it directly186descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
- K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · cites it directly77descendants
- K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa) · 2009 · 2 generations on51descendants
- K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| +1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| +1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| +2 | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| +2 | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 14 | 0 |
| 2014 | 18 | 0 |
| 2015 | 18 | 0 |
| 2016 | 13 | 0 |
| 2017 | 24 | 0 |
| 2018 | 16 | 0 |
| 2019 | 16 | 0 |
| 2020 | 17 | 0 |
| 2021 | 21 | 0 |
| 2022 | 23 | 0 |
| 2023 | 30 | 0 |
| 2024 | 40 | 0 |
| 2025 | 33 | 0 |
| 2026 | 33 | 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? (2)
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 Broad and Narrow Dynamic Compression Plates Named without a submission number | |
| * | — | Synthes Anatomical Locking Plate System Named without a submission number |
What descends from it? (340)
See all 34025 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications | 2008 | 186 |
| K112583 | Synthes Cortical Screws | 2011 | 118 |
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | 2012 | 28 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
| K141796 | Depuy Synthes Tomofix Osteotomy System | 2014 | 14 |
| K130061 | Piccolo Composite Plate System | 2013 | 10 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K072423 | 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous… | 2007 | 4 |
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, K082807 (Synthes (Usa), 2008) has gone furthest, with 186 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?
Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or tnalunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K000682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026