Cleared Traditional

K872454 - BIOMET MODULAR SHOULDER PROSTHESIS

K872454 is an FDA 510(k) clearance for BIOMET MODULAR SHOULDER PROSTHESIS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K872454 · Biomet, Inc. · Orthopedic device
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Aug 1987
Decision
65d
Days
Class 2
Risk

K872454 is an FDA 510(k) clearance for the BIOMET MODULAR SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 27, 1987 after a review of 65 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K872454

510(k) Number K872454 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1987
Decision Date August 27, 1987
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 K872454.
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · Kirschner Medical Corp. · Oct 1987
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
MONOSPHERICAL RESURFACING GLENOID PROS
K833409 · Howmedica Corp. · Nov 1983
GLENOID RESURFACING COMPONENT-3M-10816
K831233 · 3M Company · Jun 1983
GLENOID RESURFACE COMPONENT PMN 3M
K831234 · 3M Company · Jun 1983