Cleared Traditional

K943354 - SUTTER HAMMERTOE JOINT PROSTHESIS

K943354 is an FDA 510(k) clearance for SUTTER HAMMERTOE JOINT PROSTHESIS, manufactured by Sutter Corp.. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K943354 · Sutter Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
335d
Days
Class 2
Risk

K943354 is an FDA 510(k) clearance for the SUTTER HAMMERTOE JOINT PROSTHESIS. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Sutter Corp. (San Diego, US). The FDA issued a Cleared decision on June 12, 1995 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sutter Corp. devices

FDA 510(k) Submission Details - K943354

510(k) Number K943354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date June 12, 1995
Days to Decision 335 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 122d · This submission: 335d
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.

Regulatory Peers - KWH Prosthesis, Toe, Constrained, Polymer

All 15
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K943354.
ASCENT KNEE SYSTEM
K994326 · Biomet Manufacturing, Inc. · Jan 2000
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
K981194 · Nexa Orthopedics, Inc. · Jun 1998
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · Smith & Nephew Richards, Inc. · Jul 1995
ZIMMER GREAT TOE
K823405 · Zimmer, Inc. · Jan 1983
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
K801094 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980
IMPLANT, HINGE TOE, FLEX.
K780132 · Dow Corning Corp. Healthcare Industries Materials · Feb 1978