Cleared Traditional

K850444 - MEC BUTRESS PLATE

K850444 is an FDA 510(k) clearance for MEC BUTRESS PLATE, manufactured by Pfizer, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K850444 · Pfizer, Inc. · Orthopedic device
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Apr 1985
Decision
73d
Days
Class 2
Risk

K850444 is an FDA 510(k) clearance for the MEC BUTRESS 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 Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on April 19, 1985 after a review of 73 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 Pfizer, Inc. devices

FDA 510(k) Submission Details - K850444

510(k) Number K850444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1985
Decision Date April 19, 1985
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K850444.
A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM
K853709 · Downs Surgical , Ltd. · Nov 1985
LETOURNEL ACETABULAR PLATE
K850401 · Pfizer, Inc. · Apr 1985
MEC BROAD BONE PLATE
K850442 · Pfizer, Inc. · Apr 1985
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · Synthes (Usa) · May 1984
ACE BROOKER BONE PLATING SYSTEM
K833865 · Buckman Co., Inc. · Dec 1983
CRYOPHTHALMIC UNIT
K811244 · Keeler Instruments, Inc. · Jun 1981