Cleared Traditional

K861178 - DEPUY COMPRESSION HIP SCREW SYSTEM

K861178 is the FDA 510(k) clearance for DEPUY COMPRESSION HIP SCREW SYSTEM by Depuy, Inc.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K861178 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
15d
Days
Class 2
Risk

K861178 is an FDA 510(k) clearance for the DEPUY COMPRESSION HIP SCREW SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 15, 1986 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K861178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date April 15, 1986
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K861178.
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · Howmedica Corp. · Aug 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · Howmedica Corp. · Jun 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · Richards Medical Co., Inc. · Mar 1987
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205 · Kirschner Medical Corp. · Nov 1985
MEC DISTAL FEMORAL BOLT
K850403 · Pfizer, Inc. · Jul 1985
MEC HIP BOLT
K850413 · Pfizer, Inc. · Jul 1985