# K000684: Small Fragment Dynamic Compression Locking (DCL) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 28, 2000 after 59 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
965 later devices descend from it; 69 cite it directly.
1 of 966 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes 3.5mm 90° Cannulated Limited Contact Angled Blade Plates: named in the summary without a submission number
- (no number) Synthes Small Reconstruction Plates: named in the summary without a submission number
- (no number) Synthes 2.7mm Reconstruction Plates: named in the summary without a submission number
- (no number) Synthes Small T-Plate: named in the summary without a submission number

## Most influential descendants
- K011335: Synths One-Third Tubular DCL Plate (2001), 840 descendants of its own
- K012655: Congruent Bone Plate System (2001), 792 descendants of its own
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) (2003), 690 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K062216: Peri-Loc Periarticular Locked Plating System (2006), 501 descendants of its own

## Recalls of this device
- May 13, 2015 · Class II · Z-1800-2015: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

## Indications for use
Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K000684
Methodology: https://510kreport.com/methodology