# K033995: 3.5 MM LCP Distal Humerus System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 1, 2004 after 68 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.
624 later devices descend from it; 24 cite it directly.
1 of 625 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 3.5 mm LCP Reconstruction Plate: named in the summary without a submission number
- (no number) Synthes 2.4 mm Cortex Screw, self-tapping: named in the summary without a submission number

## Most influential descendants
- 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
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own

## Recalls of this device
- Mar 8, 2013 · Class II · Z-2278-2013: Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).

## Indications for use
The Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Source page: https://510kreport.com/device/K033995
Methodology: https://510kreport.com/methodology