Cleared Traditional

K870786 - AXIAL COMPRESSION SCREW

K870786 is an FDA 510(k) clearance for AXIAL COMPRESSION SCREW, manufactured by Straub Clinic and Hospital. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K870786 · Straub Clinic and Hospital · Orthopedic device
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Jun 1987
Decision
95d
Days
Class 2
Risk

K870786 is an FDA 510(k) clearance for the AXIAL COMPRESSION SCREW. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Straub Clinic and Hospital (Honolulu, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 95 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K870786

510(k) Number K870786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date June 01, 1987
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 401
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K870786.
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · Howmedica Corp. · Aug 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · Howmedica Corp. · Jun 1987
KRONNER COLLES-FOREARM EXTERNAL FIXATION
K871248 · Kronner Medical · Jun 1987
KRONNER UNIVERSAL FRAME EXTERNAL FIXATION
K871247 · Kronner Medical · May 1987
KRONNER BI-PLANER TIBIA EXTERNAL FIXATION
K871249 · Kronner Medical · May 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · Richards Medical Co., Inc. · Mar 1987
K870786 · AXIAL COMPRESSION SCREW
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