Cleared Traditional

K131984 - SYNTHES SYNSONIC ULNA NAIL

K131984 is an FDA 510(k) clearance for SYNTHES SYNSONIC ULNA NAIL, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K131984 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
276d
Days
Class 2
Risk

K131984 is an FDA 510(k) clearance for the SYNTHES SYNSONIC ULNA NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on March 31, 2014 after a review of 276 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 - K131984

510(k) Number K131984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date March 31, 2014
Days to Decision 276 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
154d slower than avg
Panel avg: 122d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K131984.
PRECICE TRAUMA NAIL SYSTEM
K141447 · Ellipse Technologies, Inc. · Jun 2014
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
K131609 · Xiamen Double Engine Medical Material Co., Ltd. · May 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · Ellipse Technologies, Inc. · May 2014
METALLIC INTRAMEDULLARY NAIL SYSTEM
K132078 · Tianjin Walkman Biomaterial Co., Ltd. · Mar 2014
VAN HIP FRACTURE SYSTEM
K133104 · Epix Orthopaedic, Corp. · Mar 2014
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
K132945 · I.T.S. GmbH · Mar 2014