Cleared Traditional

K121601 - SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP AN...

K121601 is the FDA 510(k) clearance for SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP AN... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K121601 · Synthes (Usa) · Orthopedic device
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Jul 2012
Decision
35d
Days
Class 2
Risk

K121601 is an FDA 510(k) clearance for the SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL.... 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) (West Chester, US). The FDA issued a Cleared decision on July 6, 2012 after a review of 35 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 K121601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date July 06, 2012
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K121601.
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K113652 · Aap Implantate AG · Aug 2012
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