Cleared Traditional

K131186 - SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM

K131186 is an FDA 510(k) clearance for SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE ..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K131186 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
166d
Days
Class 2
Risk

K131186 is an FDA 510(k) clearance for the SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM. 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 Products, LLC (West Chester, US). The FDA issued a Cleared decision on October 8, 2013 after a review of 166 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 Products, LLC devices

FDA 510(k) Submission Details - K131186

510(k) Number K131186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2013
Decision Date October 08, 2013
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131186.
WOLF LONG BONE PLATE SYSTEM
K131834 · Toby Orthopaedics · Nov 2013
2.5MM INLINE FUSION PLATE
K131867 · Biomet, Inc. · Oct 2013
VARIAX 2 SYSTEM
K132502 · Stryker Trauma AG · Oct 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554 · Aap Implantate AG · Oct 2013
LOCKING PLATE SYSTEM
K132642 · Beijing Libeier Bio-Engineering Institute Co., Ltd. · Oct 2013
ARTHREX COMPRESSION PLATES
K130510 · Arthrex, Inc. · Sep 2013