Cleared Traditional

K022886 - METATARSOPHALANGEAL FLEXIBLE STABILIZIN...

K022886 is the FDA 510(k) clearance for METATARSOPHALANGEAL FLEXIBLE STABILIZIN... by Osteomed Corp.. It is a Class 2 Orthopedic device (product code KWH) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K022886 · Osteomed Corp. · Orthopedic device
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Nov 2002
Decision
87d
Days
Class 2
Risk

K022886 is an FDA 510(k) clearance for the METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on November 25, 2002 after a review of 87 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 Osteomed Corp. devices

Submission Details

510(k) Number K022886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date November 25, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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.

Regulatory Peers - KWH Prosthesis, Toe, Constrained, Polymer

All 9
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K022886.
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
ASCENT KNEE SYSTEM
K994326 · Biomet Manufacturing, Inc. · Jan 2000
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · Smith & Nephew Richards, Inc. · Jul 1995
ZIMMER GREAT TOE
K823405 · Zimmer, Inc. · Jan 1983