Cleared Traditional

K850413 - MEC HIP BOLT

K850413 is the FDA 510(k) clearance for MEC HIP BOLT by Pfizer, Inc.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K850413 · Pfizer, Inc. · Orthopedic device
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Jul 1985
Decision
161d
Days
Class 2
Risk

K850413 is an FDA 510(k) clearance for the MEC HIP BOLT. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 161 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 Pfizer, Inc. devices

Submission Details

510(k) Number K850413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date July 15, 1985
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
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 272
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K850413.
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · Richards Medical Co., Inc. · Mar 1987
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · Depuy, Inc. · Apr 1986
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205 · Kirschner Medical Corp. · Nov 1985
TROCHANTER CABLE GRIP SYSTEM
K844068 · Howmedica Corp. · Jun 1985
T.O.D. PLATE SYSTEM
K842681 · Kirschner Medical Corp. · Sep 1984
T.O.D. PLATE SYS STERILE
K842695 · Kirschner Medical Corp. · Sep 1984