Cleared Traditional

K800806 - I.C.S. MINI & SMALL FRAGMENT SET

K800806 is the FDA 510(k) clearance for I.C.S. MINI & SMALL FRAGMENT SET by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K800806 · Howmedica Corp. · Orthopedic device
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Apr 1980
Decision
11d
Days
Class 2
Risk

K800806 is an FDA 510(k) clearance for the I.C.S. MINI & SMALL FRAGMENT SET. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 11 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 Howmedica Corp. devices

Submission Details

510(k) Number K800806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1980
Decision Date April 21, 1980
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K800806.
CRYOPHTHALMIC UNIT
K811244 · Keeler Instruments, Inc. · Jun 1981
CURVED SHERMAN BONE PLATE
K810061 · Howmedica Corp. · Jan 1981
POLYETHYLENE FILLED BONE PLATE
K801603 · Zimmer, Inc. · Oct 1980
MULTIPLICITY OF PRODUCTS
K782123 · Depuy, Inc. · Jan 1979
B.G. COMPRESSION SYSTEM
K770128 · Howmedica Corp. · Jan 1977
GALLENAUGH BONE PLATES
K761150 · Orthopedic Equipment Co., Inc. · Dec 1976