Cleared Traditional

K961413 - SYNTHES ANATOMICAL LOCKING PLATE SYSTEM

K961413 is an FDA 510(k) clearance for SYNTHES ANATOMICAL LOCKING PLATE SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K961413 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
117d
Days
Class 2
Risk

K961413 is an FDA 510(k) clearance for the SYNTHES ANATOMICAL LOCKING PLATE SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K961413

510(k) Number K961413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1996
Decision Date August 07, 1996
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K961413.
COMPRESSION SCREW
K962779 · Orthopaedic Biosystems, Ltd. · Aug 1996
INTERFERENCE SCREW
K960962 · Linvatec Corp. · Aug 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960940 · Linvatec Corp. · Aug 1996
MEDICINELODGE, INC. SET SCREW
K961905 · Medicinelodge, Inc. · Aug 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · Synthes (Usa) · Aug 1996
SUBTALAR MBA SYSTEM
K960692 · Kinetikos Medical, Inc. · Jul 1996