Cleared Traditional

K022887 - INTERPHALANGEAL FLEXIBLE STABILIZING RO...

K022887 is the FDA 510(k) clearance for INTERPHALANGEAL FLEXIBLE STABILIZING RO... by Osteomed Corp.. It is a Class 2 Orthopedic device (product code KWH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K022887 · Osteomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
88d
Days
Class 2
Risk

K022887 is an FDA 510(k) clearance for the INTERPHALANGEAL 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 26, 2002 after a review of 88 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 K022887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date November 26, 2002
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K022887.
NewPrim System
K191966 · Brm Extremities · Feb 2020
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · 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