Cleared Traditional

K071264 - SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE

K071264 is an FDA 510(k) clearance for SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT M..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K071264 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
66d
Days
Class 2
Risk

K071264 is an FDA 510(k) clearance for the SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE. 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 9, 2007 after a review of 66 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

FDA 510(k) Submission Details - K071264

510(k) Number K071264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date July 09, 2007
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K071264.
SBI RHEAD PLATING SYSTEM
K071549 · Small Bone Innovations, Inc. · Aug 2007
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
K071105 · Osteomed LP · Jul 2007
ACUMED CONGRUENT BONE PLATE SYSTEM
K071715 · Acumed, LLC · Jul 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946 · Synthes (Usa) · Jun 2007
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
K070793 · Small Bone Innovations, Inc. · May 2007