# K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 1, 2009 after 84 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
205 later devices descend from it; 18 cite it directly.
1 of 206 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 Modular Mini Fragment LCP System: named in the summary without a submission number
- (no number) Synthes Stainless Steel Modular Hand System: named in the summary without a submission number

## Most influential descendants
- K112885: Zimmer Plates and Screws System Screws Only (2011), 135 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K090047
Methodology: https://510kreport.com/methodology