Cleared Special

K051190 - XENFORM SOFT TISSUE REPAIR MATRIX (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051190 · Tei Biosciences, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
31d
Days
Class 2
Risk

K051190 is an FDA 510(k) clearance for the XENFORM SOFT TISSUE REPAIR MATRIX. Classified as Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code PAJ), Class II - Special Controls.

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on June 10, 2005 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tei Biosciences, Inc. devices

Submission Details

510(k) Number K051190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date June 10, 2005
Days to Decision 31 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 160d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PAJ Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Bridging Material To Attach The Vaginal Apex Or Uterus To The Sacral Promontory; Procedures Include Abdominal Sacrocolpopexy, Laparoscopic Sacrocolpopexy And Robot-assisted Sacrocolpopexy.
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 Obstetrics & Gynecology devices follow this clearance model.