Cleared Traditional

K070758 - STRYKER PEEK ZIP SUTURE ANCHOR

K070758 is the FDA 510(k) clearance for STRYKER PEEK ZIP SUTURE ANCHOR by Stryker Endoscopy. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K070758 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
57d
Days
Class 2
Risk

K070758 is an FDA 510(k) clearance for the STRYKER PEEK ZIP SUTURE ANCHOR. 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 Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on May 16, 2007 after a review of 57 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 Stryker Endoscopy devices

Submission Details

510(k) Number K070758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date May 16, 2007
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 437
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K070758.
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · Arthrocare Corp. · Aug 2007
STRYKER PEEK TWINLOOP TAC
K070882 · Stryker Endoscopy · Jul 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · Biomet, Inc. · Jul 2007
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
K070227 · Arthrocare Corp. · Apr 2007
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · Arthrocare Corp. · Jul 2006
KINSA SUTURE ANCHOR
K061154 · Smith & Nephew, Inc. · Jun 2006