Cleared Traditional

K071157 - STRYKER PEEK AND TITANIUM SOFT EYELET A...

K071157 is the FDA 510(k) clearance for STRYKER PEEK AND TITANIUM SOFT EYELET A... by Stryker Endoscopy. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K071157 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
145d
Days
Class 2
Risk

K071157 is an FDA 510(k) clearance for the STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on September 17, 2007 after a review of 145 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

Submission Details

510(k) Number K071157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2007
Decision Date September 17, 2007
Days to Decision 145 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
23d slower than avg
Panel avg: 122d · This submission: 145d
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 636
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K071157.
AAP CANNULATED SCREW AND DARCO HEADED SCREW
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DOMINATOR
K072127 · Biocomposites, Ltd. · Aug 2007
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K071952 · Biocomposites, Ltd. · Aug 2007