Cleared Traditional

K820813 - LESSER METATARSAL PHALANG. JOINT PROSTH

K820813 is an FDA 510(k) clearance for LESSER METATARSAL PHALANG. JOINT PROSTH, manufactured by Sutter Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K820813 · Sutter Biomedical, Inc. · Orthopedic device
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May 1982
Decision
59d
Days
Class 2
Risk

K820813 is an FDA 510(k) clearance for the LESSER METATARSAL PHALANG. JOINT PROSTH. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Sutter Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982 after a review of 59 days - a notably fast clearance 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: 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 - K820813

510(k) Number K820813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date May 21, 1982
Days to Decision 59 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 faster than avg
Panel avg: 122d · This submission: 59d
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 K820813.
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