Cleared Traditional

K100630 - G-FORCE PEEK SUTURE ANCHOR SYSTEM

K100630 is an FDA 510(k) clearance for G-FORCE PEEK SUTURE ANCHOR SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K100630 · Wrightmedicaltechnologyinc · Orthopedic device
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Jun 2010
Decision
98d
Days
Class 2
Risk

K100630 is an FDA 510(k) clearance for the G-FORCE PEEK SUTURE ANCHOR 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 Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 11, 2010 after a review of 98 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K100630

510(k) Number K100630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date June 11, 2010
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 580
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K100630.
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K101184 · Arthrocare Corp. · May 2010
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K100579 · Wrightmedicaltechnologyinc · Mar 2010