Cleared Traditional

K926579 - TECHMEDICA 6.5MM SELF-TAPPING CANCELLOU...

K926579 is an FDA 510(k) clearance for TECHMEDICA 6.5MM SELF-TAPPING CANCELLOU..., manufactured by Techmedica, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K926579 · Techmedica, Inc. · Orthopedic device
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Apr 1993
Decision
133d
Days
Class 2
Risk

K926579 is an FDA 510(k) clearance for the TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Techmedica, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 6, 1993 after a review of 133 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 Techmedica, Inc. devices

FDA 510(k) Submission Details - K926579

510(k) Number K926579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1992
Decision Date April 06, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K926579.
BONE SCREWS
K923841 · Instrument Makar, Inc. · Oct 1993
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · Acufex Microsurgical, Inc. · Aug 1993
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · Osteomed Corp. · Apr 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993