Cleared Traditional

K102601 - ORTHOFLEX ROD

K102601 is an FDA 510(k) clearance for ORTHOFLEX ROD, manufactured by Ortho-Pro, LLC. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K102601 · Ortho-Pro, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
127d
Days
Class 2
Risk

K102601 is an FDA 510(k) clearance for the ORTHOFLEX ROD. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Ortho-Pro, LLC (Round Rock, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 127 days - within the typical 510(k) review window.

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: 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.

View all Ortho-Pro, LLC devices

FDA 510(k) Submission Details - K102601

510(k) Number K102601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2010
Decision Date January 14, 2011
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K102601.
Fusion Silastic System
K190136 · Fusion Orthopedics, LLC · Oct 2019
RTS Lesser MTP Implant System
K173491 · In2bones USA, LLC · Feb 2018
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · In2bones USA, LLC · Sep 2016
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · Nexa Orthopedics, Inc. · Jan 2003
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · Osteomed Corp. · Nov 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · Osteomed Corp. · Nov 2002