Cleared Traditional

K221947 - Tyber Medical Staple Fixation System (v...

K221947 is the FDA 510(k) clearance for Tyber Medical Staple Fixation System (v... by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K221947 · Tyber Medical, LLC · Orthopedic device
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Oct 2022
Decision
107d
Days
Class 2
Risk

K221947 is an FDA 510(k) clearance for the Tyber Medical Staple Fixation System (various). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on October 20, 2022 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Tyber Medical, LLC devices

Submission Details

510(k) Number K221947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2022
Decision Date October 20, 2022
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K221947.
JAWS Nitinol Staple System
K230550 · Paragon 28, Inc. · May 2023
JAWS Nitinol Staple System
K223056 · Paragon 28, Inc. · Feb 2023
Treace Medical Concepts (TMC) Implant Fixation System
K222645 · Treace Medical Concepts · Nov 2022
DynaClip® Bone Staple
K220812 · MedShape, Inc. · Aug 2022
EasyClip® and EasyClip® Xpress
K210582 · Stryker GmbH · Jun 2022
StealthFix Intraosseous Fixation System
K220181 · Nextremity Solutions, Inc. · Mar 2022