Cleared Traditional

K220812 - DynaClip® Bone Staple

K220812 is an FDA 510(k) clearance for DynaClip Bone Staple, manufactured by MedShape, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K220812 · MedShape, Inc. · Orthopedic device
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Aug 2022
Decision
151d
Days
Class 2
Risk

K220812 is an FDA 510(k) clearance for the DynaClip® Bone Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by MedShape, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 19, 2022 after a review of 151 days - an extended review cycle.

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 MedShape, Inc. devices

FDA 510(k) Submission Details - K220812

510(k) Number K220812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2022
Decision Date August 19, 2022
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 K220812.
JAWS Nitinol Staple System
K223056 · Paragon 28, Inc. · Feb 2023
Treace Medical Concepts (TMC) Implant Fixation System
K222645 · Treace Medical Concepts · Nov 2022
Tyber Medical Staple Fixation System (various)
K221947 · Tyber Medical, LLC · Oct 2022
EasyClip® and EasyClip® Xpress
K210582 · Stryker GmbH · Jun 2022
StealthFix Intraosseous Fixation System
K220181 · Nextremity Solutions, Inc. · Mar 2022
FuseForce™ Flex Dynamic Compression System
K203832 · Wright Medical · May 2021