Cleared Traditional

K102262 - ARTHOCARE SPARTAN PEEK SUTURE IMPLANT S...

Also marketed or referenced as:
PUNCH TAP EXTRACTION TOOL

K102262 is the FDA 510(k) clearance for ARTHOCARE SPARTAN PEEK SUTURE IMPLANT S... by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K102262 · Arthrocare Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
72d
Days
Class 2
Risk

K102262 is an FDA 510(k) clearance for the ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM. 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 Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on October 21, 2010 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K102262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date October 21, 2010
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K102262.
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · Arthrocare Corp. · Feb 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · Arthrex, Inc. · Jan 2011
SPEEDFIX SUTURE SYSTEM
K101437 · Arthrocare Corp. · Oct 2010
INTRAFIX TIBIAL SHEATH
K102443 · Depuy Mitek, A Johnson & Johnson Company · Oct 2010
OPUS SPEEDSCREW SYSTEM
K101448 · Arthrocare Corp. · Jun 2010
G-FORCE PEEK SUTURE ANCHOR SYSTEM
K100630 · Wrightmedicaltechnologyinc · Jun 2010