Cleared Traditional

GAP ENDO-EXO MEDULLARY SYSTEM (K160545) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160545 · Pega Medical, Inc. · Orthopedic device
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Nov 2016
Decision
271d
Days
Class 2
Risk

K160545 is an FDA 510(k) clearance for the GAP ENDO-EXO MEDULLARY SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Pega Medical, Inc. (Laval, CA). The FDA issued a Cleared decision on November 23, 2016 after a review of 271 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Pega Medical, Inc. devices

Submission Details

510(k) Number K160545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date November 23, 2016
Days to Decision 271 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 122d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 262
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K160545.
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Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015