Cleared Traditional

K173693 - Orbitum Bone Staple Implant

K173693 is the FDA 510(k) clearance for Orbitum Bone Staple Implant by Orthovestments, LLC. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K173693 · Orthovestments, LLC · Orthopedic device
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Feb 2018
Decision
84d
Days
Class 2
Risk

K173693 is an FDA 510(k) clearance for the Orbitum Bone Staple Implant, X and VI. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Orthovestments, LLC (Marietta, US). The FDA issued a Cleared decision on February 23, 2018 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthovestments, LLC devices

Submission Details

510(k) Number K173693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2017
Decision Date February 23, 2018
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K173693.
DePuy Synthes Static Staples
K180544 · Synthes USA Products, LLC · Jul 2018
MotoCLIP/HiMAX Implant System
K181410 · Crossroads Extremity Systems, LLC · Jun 2018
Clench Compression Staple
K173775 · F & A Foundation, LLC D.B.A. Reign Medical · Apr 2018
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
Arthrex DynaNite Nitinol Staple
K172052 · Arthrex, Inc. · Dec 2017
EasyStep
K160813 · Stryker GmbH · Jul 2016