Cleared Traditional

K875249 - SUTTER PHALANGEAL CAP

K875249 is an FDA 510(k) clearance for SUTTER PHALANGEAL CAP, manufactured by Sutter Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K875249 · Sutter Biomedical, Inc. · Orthopedic device
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Feb 1988
Decision
43d
Days
Class 2
Risk

K875249 is an FDA 510(k) clearance for the SUTTER PHALANGEAL CAP. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Sutter Biomedical, Inc. (San Diego, US). The FDA issued a Cleared decision on February 3, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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 Sutter Biomedical, Inc. devices

FDA 510(k) Submission Details - K875249

510(k) Number K875249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date February 03, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWD Device Classification - Class 2, Special Controls

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 38
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K875249.
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · Kinetikos Medical, Inc. · Dec 2002
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · Nexa Orthopedics, Inc. · Jun 1997
TOWNLEY GREAT TOE JOINT
K911378 · Biopro, Inc. · Nov 1991
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · Dow Corning Wright · Apr 1987
IMPLANT, H.P. CONDYLAR
K781870 · Dow Corning Corp. Healthcare Industries Materials · Feb 1979