Cleared Traditional

K833409 - MONOSPHERICAL RESURFACING GLENOID PROS

K833409 is the FDA 510(k) clearance for MONOSPHERICAL RESURFACING GLENOID PROS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWT) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K833409 · Howmedica Corp. · Orthopedic device

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Nov 1983

Decision

38d

Days

Class 2

Risk

K833409 is an FDA 510(k) clearance for the MONOSPHERICAL RESURFACING GLENOID PROS. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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	K833409 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 1983
Decision Date	November 07, 1983
Days to Decision	38 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

84d faster than avg

Panel avg: 122d · This submission: 38d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 888.3650

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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 59

Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K833409.

NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.

K873620 · Kirschner Medical Corp. · Oct 1987

NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS

K873621 · Kirschner Medical Corp. · Oct 1987

BIOMET MODULAR SHOULDER PROSTHESIS

K872454 · Biomet, Inc. · Aug 1987

GLENOID RESURFACING COMPONENT-3M-10816

K831233 · 3M Company · Jun 1983

GLENOID RESURFACE COMPONENT PMN 3M

K831234 · 3M Company · Jun 1983

GRISTINA GLENOID PROSTHESIS

K802124 · Howmedica Corp. · Dec 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833409

Howmedica Corp.

Mchenry, IL · US

Regulatory profile

373 submissions 325 cleared

87% clearance rate · Active in Orthopedic

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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