Cleared Traditional

K221947 - Tyber Medical Staple Fixation System (various)

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

K221947 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K221947

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.

JDR Device Classification - Class 2, Special Controls

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 191
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