Cleared Traditional

K905795 - SGARLATO FLEXIBLE HINGE TOE IMPLANT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905795 · Sgarlato Laboratories, Inc. · Orthopedic device
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May 1991
Decision
153d
Days
Class 2
Risk

K905795 is an FDA 510(k) clearance for the SGARLATO FLEXIBLE HINGE 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 29, 1991 after a review of 153 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

Submission Details

510(k) Number K905795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date May 29, 1991
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.