510(k) · Cleared
Recalled · Class II · 2015Small 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 Apr 28, 2000 after a 59-day review. The FDA summary names its predicate without a number. 1 of the 966 devices in its family, counting itself, has a Class I recall. 965 later devices descend from it. It has been recalled once.
- Decided
- Apr 28, 2000
- Review
- 59 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
965 later devices descend from it, 69 citing it directly. 1 of the 966 devices in this family, counting this one, has a Class I recall.
- This deviceK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- Descendant · cites it directly · 840 of its ownK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- Descendant · 2 generations on · 792 of its ownK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- Descendant · cites it directly · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- Descendant · cites it directly · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
Showing 5 of 965 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 965 · See all- K011335Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · cites it directly840descendants
- K012655Congruent Bone Plate SystemAcu Med, Inc. · 2001 · 2 generations on792descendants
- K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · cites it directly690descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · cites it directly584descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · 2 generations on501descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| +1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| +2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| +1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| +1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +2 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 10 | 0 |
| 2006 | 13 | 0 |
| 2007 | 9 | 0 |
| 2008 | 9 | 0 |
| 2009 | 12 | 0 |
| 2010 | 18 | 0 |
| 2011 | 34 | 0 |
| 2012 | 33 | 0 |
| 2013 | 36 | 0 |
| 2014 | 54 | 0 |
| 2015 | 61 | 0 |
| 2016 | 38 | 0 |
| 2017 | 73 | 0 |
| 2018 | 38 | 0 |
| 2019 | 48 | 0 |
| 2020 | 57 | 0 |
| 2021 | 58 | 1 |
| 2022 | 56 | 0 |
| 2023 | 61 | 0 |
| 2024 | 79 | 0 |
| 2025 | 73 | 0 |
| 2026 | 87 | 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.
1 device in this family has a Class I recall. 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? (4)
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 3.5mm 90° Cannulated Limited Contact Angled Blade Plates Named without a submission number | |
| * | — | Synthes Small Reconstruction Plates Named without a submission number | |
| * | — | Synthes 2.7mm Reconstruction Plates Named without a submission number | |
| * | — | Synthes Small T-Plate Named without a submission number |
What descends from it? (965)
See all 96569 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011335 | Synths One-Third Tubular DCL Plate | 2001 | 840 |
| K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | 2003 | 690 |
| K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | 2005 | 584 |
| K050457 | Merete Metafix Small Fragment Bone Plate System | 2005 | 258 |
| K063487 | Merete BLP Small Fragment Locking Bone Plate | 2007 | 257 |
| K081513 | Merete 3.0 and 3.5 MM Locking Screws | 2008 | 256 |
| K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | 2006 | 187 |
| 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 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2015 | Class II | Z-1800-2015 | Employee error | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K011335 (Synthes (Usa), 2001) has gone furthest, with 840 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?
Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
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/K000684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000684: Small Fragment Dynamic Compression Locking (DCL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000684
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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