Synthes (USA) 3.5mm Lcp Periarticular Proximal Humerus Plates

• • Terminated Z-0309-2011 FDA Unclassified (pre-2012) ·initiated 16 Sep 2010

  screw can pass through plate hole

510(k) Number

K082625 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What types of injuries or conditions are these plates specifically designed to stabilize in the proximal humerus area?

  These 3.5 mm LCP Periarticular Proximal Humerus Plates are designed for stabilizing proximal humerus fractures, fracture dislocations, osteotomies (surgical bone cuts), and nonunions (failed bone healing). The locking screw technology ensures angular stability, which is particularly useful in osteopenic (low bone density) bone to maintain secure fixation during healing.

• Are these plates reusable or intended for single-use, and how should they be stored?

  The plates are supplied sterile and intended for single-use only. Storage and handling must follow sterile medical device protocols to maintain integrity, as they are part of the Small Fragment LCP System and not designed for reprocessing.

• What makes the anatomical design of these plates unique, and how does it benefit the surgeon?

  The plates feature an anatomical design that accommodates both left and right humerus applications, allowing for precise alignment and restoration of bone integrity. This reduces the need for customization and ensures a better fit during proximal humerus surgeries, improving fixation accuracy.

• How do the Combi holes on these plates enhance their versatility in surgical applications?

  The Combi holes enable flexibility in screw placement—surgeons can use locking screws in threaded sections for angular stability or cortex screws in dynamic compression units for compression-based fixation. This adaptability allows tailored fixation strategies depending on the fracture pattern or clinical needs.

• What regulatory pathway was followed for FDA clearance of these plates, and what does that mean for their use?

  The plates received FDA 510(k) clearance (K082625) under a *Traditional* review pathway, determined to be *Substantially Equivalent* to a predicate device. This means they meet FDA standards for safety and effectiveness as an orthopedic fixation device, intended exclusively for use in surgical settings as described in the labeling.