Cleared Traditional

K911306 - T-BOLT AND NUT

K911306 is an FDA 510(k) clearance for T-BOLT AND NUT, manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K911306 · Danek Medical, Inc. · Orthopedic device
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Sep 1991
Decision
169d
Days
Class 2
Risk

K911306 is an FDA 510(k) clearance for the T-BOLT AND NUT. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 169 days - an extended review 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: 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 - K911306

510(k) Number K911306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date September 10, 1991
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 69
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K911306.
BONE SCREW WASHER
K943782 · Acu Med, Inc. · Dec 1994
SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
K924455 · Synthes (Usa) · May 1993
SPIKED WASHER
K914472 · Synthes (Usa) · Nov 1991
WYMAN SUTURE WASHER
K910186 · Acu Med, Inc. · Jul 1991
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
K910229 · Depuy, Inc. · Jul 1991
ACE ORTHOPAEDIC WASHERS
K895107 · Buckman Co., Inc. · Sep 1989