# K011335: Synths One-Third Tubular DCL Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 27, 2001 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000684 (2000). 1 ancestor in all.
840 later devices descend from it; 43 cite it directly.
1 of 842 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- (no number) Synthes Third Tubular Plate (Pre-Amendment): named in the summary without a submission number

## Most influential descendants
- K012655: Congruent Bone Plate System (2001), 792 descendants of its own
- K051735: Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (2005), 584 descendants of its own
- K071563: Peri-Loc Periarticular Locked Plating System (2007), 495 descendants of its own
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories (2009), 487 descendants of its own
- K021626: Hallu Plates (2002), 280 descendants of its own

## Recalls of this device
- Jul 21, 2020 · Class II · Z-2816-2020: May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially resu
- Feb 22, 2013 · Class II · Z-1557-2013: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

## Indications for use
Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.

Source page: https://510kreport.com/device/K011335
Methodology: https://510kreport.com/methodology