Cleared Traditional

K873621 - NEER-III SOLID KEEL GLENOID RESURFACING...

K873621 is an FDA 510(k) clearance for NEER-III SOLID KEEL GLENOID RESURFACING..., manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K873621 · Kirschner Medical Corp. · Orthopedic device
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Oct 1987
Decision
37d
Days
Class 2
Risk

K873621 is an FDA 510(k) clearance for the NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 37 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K873621

510(k) Number K873621 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 08, 1987
Decision Date October 15, 1987
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

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 K873621.
GLOBAL TOTAL SHOULDER
K905786 · Depuy, Inc. · Mar 1991
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · Kirschner Medical Corp. · Oct 1987
NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
K873620 · Kirschner Medical Corp. · Oct 1987
BIOMET MODULAR SHOULDER PROSTHESIS
K872454 · Biomet, Inc. · Aug 1987
MONOSPHERICAL RESURFACING GLENOID PROS
K833409 · Howmedica Corp. · Nov 1983
GLENOID RESURFACING COMPONENT-3M-10816
K831233 · 3M Company · Jun 1983