Cleared Traditional

K813371 - GROSSE AND KEMPF LOCKING NAIL SYS.

K813371 is the FDA 510(k) clearance for GROSSE AND KEMPF LOCKING NAIL SYS. by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K813371 · Howmedica Corp. · Orthopedic device
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Mar 1982
Decision
91d
Days
Class 2
Risk

K813371 is an FDA 510(k) clearance for the GROSSE AND KEMPF LOCKING NAIL SYS.. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Corp. (Walker, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Howmedica Corp. devices

Submission Details

510(k) Number K813371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date March 01, 1982
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K813371.
FEMOROTIBIAL MEDULLARY NAIL
K853250 · Zimmer, Inc. · Feb 1986
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
K854338 · Kirschner Medical Corp. · Dec 1985
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K850142 · Buckman Co., Inc. · Feb 1985
ENDER PINS
K811002 · Richard'S Medical Equip., Inc. · Apr 1981
MOURADIAN MODIFIED ZICKEL HUMERAL ROD
K810535 · Howmedica Corp. · Mar 1981
FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM
K803196 · Howmedica Corp. · Feb 1981