Cleared Traditional

K911319 - TSRH OPEN HEAD BONE SCREW

K911319 is an FDA 510(k) clearance for TSRH OPEN HEAD BONE SCREW, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K911319 · Danek Medical, Inc. · Orthopedic device
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Sep 1991
Decision
164d
Days
Class 2
Risk

K911319 is an FDA 510(k) clearance for the TSRH OPEN HEAD BONE SCREW. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 164 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K911319

510(k) Number K911319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date September 06, 1991
Days to Decision 164 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K911319.
RAY SACRAL FIXATION SYSTEM
K904520 · Danek Medical, Inc. · Oct 1991
CROSSLINK PLATE
K911307 · Danek Medical, Inc. · Oct 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · Danek Medical, Inc. · Sep 1991
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528 · Acromed Corp. · Jun 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394 · Acromed Corp. · Jun 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826 · Acromed Corp. · Mar 1991