Cleared Traditional

K801094 - SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL

K801094 is an FDA 510(k) clearance for SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K801094 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
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Jun 1980
Decision
32d
Days
Class 2
Risk

K801094 is an FDA 510(k) clearance for the SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3720 - 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K801094

510(k) Number K801094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1980
Decision Date June 09, 1980
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWH Device Classification - Class 2, Special Controls

Product Code KWH Prosthesis, Toe, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3720
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.