Cleared Traditional

K161426 - NeoSpan Compression Staple Impant w/instruments

K161426 is an FDA 510(k) clearance for NeoSpan Compression Staple Impant w/ins..., manufactured by In2bones USA, LLC. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K161426 · In2bones USA, LLC · Orthopedic device
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Oct 2016
Decision
154d
Days
Class 2
Risk

K161426 is an FDA 510(k) clearance for the NeoSpan Compression Staple Impant w/instruments. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on October 24, 2016 after a review of 154 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 In2bones USA, LLC devices

FDA 510(k) Submission Details - K161426

510(k) Number K161426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date October 24, 2016
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
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 Consultant

Enmed International, Inc.
LOUISE FOCHT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDR Staple, Fixation, Bone

All 208
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K161426.
EasyClip Xpress
K162321 · Restore Surgical, LLC Dba Instratek · Feb 2017
Memodyn Staple
K161587 · Austin & Associates, Inc./Telos Medical Equipment · Feb 2017
Stealth Staple System
K163440 · First Ray, LLC · Feb 2017
EasyStep
K160813 · Stryker GmbH · Jul 2016
First Ray Internal Bone Staple System
K153622 · First Ray, LLC · Apr 2016
OS2(R)-VP Varisation Staple
K153770 · In2bones Sas · Mar 2016