Cleared Traditional

K974017 - TIMESH SYSTEM

K974017 is an FDA 510(k) clearance for TIMESH SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K974017 · Sofamor Danek USA,Inc. · Orthopedic device
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Jan 1998
Decision
86d
Days
Class 2
Risk

K974017 is an FDA 510(k) clearance for the TIMESH 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 Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 86 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K974017

510(k) Number K974017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1997
Decision Date January 16, 1998
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K974017.
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
EPI-UNION PLATING SYSTEM
K974289 · Howmedica, Inc. · Feb 1998
LACTOSORB PANELS
K974309 · Biomet, Inc. · Jan 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · Howmedica, Inc. · Jan 1998
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · Osteonics Corp. · Dec 1997
ORTHOPEDIC PLATE SYSTEM
K972219 · Ferguson Medical · Nov 1997