Cleared Traditional

K912640 - CONCEPT ENDOSTEAL FIXATION DEVICE

K912640 is an FDA 510(k) clearance for CONCEPT ENDOSTEAL FIXATION DEVICE, manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K912640 · Concept, Inc. · Orthopedic device
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May 1992
Decision
322d
Days
Class 2
Risk

K912640 is an FDA 510(k) clearance for the CONCEPT ENDOSTEAL FIXATION DEVICE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Concept, Inc. (Largo, US). The FDA issued a Cleared decision on May 1, 1992 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Concept, Inc. devices

FDA 510(k) Submission Details - K912640

510(k) Number K912640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1991
Decision Date May 01, 1992
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K912640.
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · Arthrex, Inc. · Feb 1993
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992
CORTICAL BONE SCREW
K915448 · Dow Corning Wright · Feb 1992
BONE SCREW 3.5 MM
K915613 · Acu Med, Inc. · Feb 1992
UNIVERSAL COMPRESION SCREW
K915124 · Howmedica Corp. · Feb 1992