Cleared Traditional

K951451 - PEBA ANCHOR (MULTIPLE SIZES)

K951451 is an FDA 510(k) clearance for PEBA ANCHOR (MULTIPLE SIZES), 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 216-day FDA review.

K951451 · Orthopaedic Biosystems, Ltd. · Orthopedic device
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Oct 1995
Decision
216d
Days
Class 2
Risk

K951451 is an FDA 510(k) clearance for the PEBA ANCHOR (MULTIPLE SIZES). 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 October 31, 1995 after a review of 216 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 - K951451

510(k) Number K951451 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 29, 1995
Decision Date October 31, 1995
Days to Decision 216 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 122d · This submission: 216d
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 510
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K951451.
MITEK THREADED ANCHOR (FASTIN)
K953560 · Mitek Surgical Products, Inc. · Jan 1996
MITEK GII ANCHOR
K953877 · Mitek Surgical Products, Inc. · Dec 1995
INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER
K952237 · Innovasive Devices, Inc. · Dec 1995
WASHER
K953702 · Linvatec Corp. · Oct 1995
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K953264 · Wrightmedicaltechnologyinc · Oct 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · Arthrex, Inc. · Sep 1995