Cleared Traditional

K062872 - SYNTHES (USA) PEDIATRIC LCP HIP PLATE S...

K062872 is the FDA 510(k) clearance for SYNTHES (USA) PEDIATRIC LCP HIP PLATE S... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K062872 · Synthes (Usa) · Orthopedic device
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Mar 2007
Decision
168d
Days
Class 2
Risk

K062872 is an FDA 510(k) clearance for the SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 13, 2007 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K062872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2006
Decision Date March 13, 2007
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K062872.
CHINA NAILS AND ACCESSORIES
K123948 · Smith & Nephew, Inc. · Mar 2013
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · Synthes (Usa) · Dec 2011
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
K072095 · Synthes (Usa) · Sep 2007
KNEE FUSION NAIL
K061783 · Smith & Nephew, Inc. · Aug 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
K061019 · Smith & Nephew, Inc. · Jun 2006
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
K051557 · Smith & Nephew, Inc. · Jun 2005