Cleared Traditional

K972326 - PEBA ANCHOR/SUTURE COMBINATION

K972326 is an FDA 510(k) clearance for PEBA ANCHOR/SUTURE COMBINATION, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K972326 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
228d
Days
Class 2
Risk

K972326 is an FDA 510(k) clearance for the PEBA ANCHOR/SUTURE COMBINATION. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scotsdale, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 228 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K972326

510(k) Number K972326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date February 06, 1998
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K972326.
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MITEK KNOTLESS ANCHOR
K974345 · Mitek Products · Feb 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · Mitek Products · Jan 1998
CRANIOFACIAL ANCHORS
K974136 · Biomet, Inc. · Jan 1998
ACL CLIP-IN
K973323 · Innovasive Devices, Inc. · Dec 1997