Cleared Traditional

K081025 - ISOELASTICU

K081025 is an FDA 510(k) clearance for ISOELASTICU, manufactured by Remi Sciences, Inc.. The device is a Class 2 Orthopedic device with product code KXE cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K081025 · Remi Sciences, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
225d
Days
Class 2
Risk

K081025 is an FDA 510(k) clearance for the ISOELASTICU. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Remi Sciences, Inc. (Lititz, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 225 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3810 - 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 Remi Sciences, Inc. devices

FDA 510(k) Submission Details - K081025

510(k) Number K081025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date November 21, 2008
Days to Decision 225 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
103d slower than avg
Panel avg: 122d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXE Device Classification - Class 2, Special Controls

Product Code KXE Prosthesis, Wrist, Hemi-, Ulnar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3810
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 - KXE Prosthesis, Wrist, Hemi-, Ulnar

All 8
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K081025.
Aptis Medical Distal Radio Ulnar Joint Implant
K190599 · Aptis Medical, LLC · May 2019
SBI ULNAR HEAD IMPLANT
K061146 · Small Bone Innovations, Inc. · Jul 2006
ASCENSION MUH
K052137 · Ascension Orthopedics, Inc. · Nov 2005
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · Wrightmedicaltechnologyinc · Feb 2002
ULNAR HEAD IMPLANT
K010786 · Avanta Orthopaedics, Inc. · Apr 2001
ULNAR HEAD IMPLANT
K982268 · Avanta Orthopaedics, Inc. · Dec 1998