# K063049: Synthes (Usa) Modular Mini Fragment LCP System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 18, 2006 after 75 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
468 later devices descend from it; 40 cite it directly.
0 of 469 devices in its family (counting itself) have 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 Stainless Steel Modular Hand System: named in the summary without a submission number
- (no number) Synthes Modular Foot System: named in the summary without a submission number
- (no number) Synthes Modular Foot System- 2.7 mm Module: named in the summary without a submission number

## Most influential descendants
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws (2010), 119 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2389-2016: It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being 
- Nov 2, 2015 · Class II · Z-0323-2016: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above pa
- Oct 6, 2015 · Class II · Z-0167-2016: Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
- Jul 31, 2013 · Class II · Z-0380-2014: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

## Indications for use
The Synthes (USA) Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

Source page: https://510kreport.com/device/K063049
Methodology: https://510kreport.com/methodology