Cleared Traditional

K884739 - SGARLATO LESSER TOE IMPLANT

K884739 is an FDA 510(k) clearance for SGARLATO LESSER TOE IMPLANT, manufactured by Sgarlato Laboratories, Inc.. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K884739 · Sgarlato Laboratories, Inc. · Orthopedic device
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May 1989
Decision
185d
Days
Class 2
Risk

K884739 is an FDA 510(k) clearance for the SGARLATO LESSER TOE IMPLANT. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Sgarlato Laboratories, Inc. devices

FDA 510(k) Submission Details - K884739

510(k) Number K884739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date May 18, 1989
Days to Decision 185 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 122d · This submission: 185d
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 K884739.
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