Cleared Traditional

K872502 - M.W.P. WRIST PROSTHESIS

K872502 is an FDA 510(k) clearance for M.W.P. WRIST PROSTHESIS, manufactured by Protek, Inc.. The device is a Class 2 Orthopedic device with product code KWM cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K872502 · Protek, Inc. · Orthopedic device
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Jul 1987
Decision
29d
Days
Class 2
Risk

K872502 is an FDA 510(k) clearance for the M.W.P. WRIST PROSTHESIS. Classified as Prosthesis, Wrist, Semi-constrained (product code KWM), Class II - Special Controls.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 23, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - 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 Protek, Inc. devices

FDA 510(k) Submission Details - K872502

510(k) Number K872502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date July 23, 1987
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWM Device Classification - Class 2, Special Controls

Product Code KWM Prosthesis, Wrist, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
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.