Cleared Traditional

K801603 - POLYETHYLENE FILLED BONE PLATE

K801603 is an FDA 510(k) clearance for POLYETHYLENE FILLED BONE PLATE, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K801603 · Zimmer, Inc. · Orthopedic device
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Oct 1980
Decision
81d
Days
Class 2
Risk

K801603 is an FDA 510(k) clearance for the POLYETHYLENE FILLED BONE PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 81 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K801603

510(k) Number K801603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1980
Decision Date October 03, 1980
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 953
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K801603.
ACE BROOKER BONE PLATING SYSTEM
K833865 · Buckman Co., Inc. · Dec 1983
CRYOPHTHALMIC UNIT
K811244 · Keeler Instruments, Inc. · Jun 1981
CURVED SHERMAN BONE PLATE
K810061 · Howmedica Corp. · Jan 1981
I.C.S. MINI & SMALL FRAGMENT SET
K800806 · Howmedica Corp. · Apr 1980
MULTIPLICITY OF PRODUCTS
K782123 · Depuy, Inc. · Jan 1979
B.G. COMPRESSION SYSTEM
K770128 · Howmedica Corp. · Jan 1977