Cleared Traditional

K092133 - ARTHROCARE TITANIUM SUTURE ANCHOR

K092133 is the FDA 510(k) clearance for ARTHROCARE TITANIUM SUTURE ANCHOR by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K092133 · Arthrocare Corp. · Orthopedic device
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Nov 2009
Decision
113d
Days
Class 2
Risk

K092133 is an FDA 510(k) clearance for the ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 113 days - within the typical 510(k) review window.

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 Arthrocare Corp. devices

Submission Details

510(k) Number K092133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date November 05, 2009
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 552
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K092133.
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
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