Cleared Traditional

K091234 - SKELTEX ISV

K091234 is an FDA 510(k) clearance for SKELTEX ISV, manufactured by Skeltex Technologies, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K091234 · Skeltex Technologies, Inc. · Orthopedic device
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Feb 2010
Decision
295d
Days
Class 2
Risk

K091234 is an FDA 510(k) clearance for the SKELTEX ISV. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Skeltex Technologies, Inc. (Boucherville, Quebec, CA). The FDA issued a Cleared decision on February 16, 2010 after a review of 295 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K091234

510(k) Number K091234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date February 16, 2010
Days to Decision 295 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 122d · This submission: 295d
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 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K091234.
KYPH X HV-R BONE CEMENT
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K090986 · Dfine, Inc. · Dec 2009
VERTECEM
K090435 · Teknimed, S.A. · Dec 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · Stryker Corp. · Oct 2009
K091234 · SKELTEX ISV
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