Cleared Traditional

K123942 - STRYKER IVAS BALLOON CATHETER

K123942 is an FDA 510(k) clearance for STRYKER IVAS BALLOON CATHETER, manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K123942 · Stryker Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
104d
Days
Class 2
Risk

K123942 is an FDA 510(k) clearance for the STRYKER IVAS BALLOON CATHETER. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 3, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Stryker Corporation devices

FDA 510(k) Submission Details - K123942

510(k) Number K123942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date April 03, 2013
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 99
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K123942.
CROSSTREES PVA POD
K130089 · Crosstrees Medical, Inc. · Aug 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
K122503 · Neuro Therm, Inc. · Jun 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
K130146 · Synthes (Usa), LLC · May 2013
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
K130402 · Sintea Plustek, LLC · Apr 2013
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
K122175 · Tecres S.P.A. · Mar 2013
OSSEOFLEX SB INFLATABLE BONE TAMP
K122533 · Osseon Therapeutics, Inc. · Oct 2012