Cleared Traditional

K070882 - STRYKER PEEK TWINLOOP TAC

K070882 is an FDA 510(k) clearance for STRYKER PEEK TWINLOOP TAC, manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K070882 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
112d
Days
Class 2
Risk

K070882 is an FDA 510(k) clearance for the STRYKER PEEK TWINLOOP TAC. 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 July 20, 2007 after a review of 112 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 Stryker Endoscopy devices

FDA 510(k) Submission Details - K070882

510(k) Number K070882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date July 20, 2007
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 602
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K070882.
BIORAPTOR 2.3 PK SUTURE ANCHOR
K071586 · Smith & Nephew Inc., Endoscopy Division · Aug 2007
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
K071520 · Core Essence Orthopaedics, LLC · Aug 2007
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · Arthrocare Corp. · Aug 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · Biomet, Inc. · Jul 2007
STRYKER PEEK ZIP SUTURE ANCHOR
K070758 · Stryker Endoscopy · May 2007
SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070908 · Smith & Nephew Inc., Endoscopy Division · May 2007