Cleared Traditional

K050110 - SYNTHES (USA) LCP MODULAR FOOT PLATES

K050110 is the FDA 510(k) clearance for SYNTHES (USA) LCP MODULAR FOOT PLATES by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K050110 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
45d
Days
Class 2
Risk

K050110 is an FDA 510(k) clearance for the SYNTHES (USA) LCP MODULAR FOOT PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K050110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date March 04, 2005
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K050110.
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · Synthes (Usa) · Apr 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · Synthes (Usa) · Apr 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · Howmedica Osteonics Corp. · Mar 2005
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
K050121 · Zimmer, Inc. · Jan 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560 · Zimmer, Inc. · Jan 2005
TRIMED OSTEOTOMY PLATE
K043263 · TriMed, Inc. · Jan 2005