Cleared Traditional

K850441 - MEC INTRAMEDULLARY ROD

K850441 is an FDA 510(k) clearance for MEC INTRAMEDULLARY ROD, manufactured by Pfizer, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K850441 · Pfizer, Inc. · Orthopedic device
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Apr 1985
Decision
73d
Days
Class 2
Risk

K850441 is an FDA 510(k) clearance for the MEC INTRAMEDULLARY ROD. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), 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 888.3020 - 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: 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 - K850441

510(k) Number K850441 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.

HSB Device Classification - Class 2, Special Controls

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K850441.
FEMOROTIBIAL MEDULLARY NAIL
K853250 · Zimmer, Inc. · Feb 1986
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
K854338 · Kirschner Medical Corp. · Dec 1985
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
K852020 · Warsaw Orthopedic, Inc. · May 1985
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K850142 · Buckman Co., Inc. · Feb 1985
GROSSE AND KEMPF LOCKING NAIL SYS.
K813371 · Howmedica Corp. · Mar 1982
ENDER PINS
K811002 · Richard'S Medical Equip., Inc. · Apr 1981