Cleared Traditional

K911378 - TOWNLEY GREAT TOE JOINT

K911378 is an FDA 510(k) clearance for TOWNLEY GREAT TOE JOINT, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K911378 · Biopro, Inc. · Orthopedic device
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Nov 1991
Decision
239d
Days
Class 2
Risk

K911378 is an FDA 510(k) clearance for the TOWNLEY GREAT TOE JOINT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 239 days - an extended review 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: 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.

FDA 510(k) Submission Details - K911378

510(k) Number K911378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date November 22, 1991
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 44
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K911378.
GREAT TOE IMPLANT SYSTEM
K014164 · Harmos Orthopaedics, Inc. · Mar 2002
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · Terray Corp. · Feb 2001
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · Nexa Orthopedics, Inc. · Jun 1997
SUTTER PHALANGEAL CAP
K875249 · Sutter Biomedical, Inc. · Feb 1988
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · Dow Corning Wright · Apr 1987
SUTTER LESSER METATARSAL CAP
K861983 · Sutter Biomedical, Inc. · Sep 1986
K911378 · TOWNLEY GREAT TOE JOINT
Download PDF Biopro, Inc.