Cleared Traditional

K161753 - Hoffman LRF System

K161753 is an FDA 510(k) clearance for Hoffman LRF System, manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K161753 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
144d
Days
Class 2
Risk

K161753 is an FDA 510(k) clearance for the Hoffman LRF System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on November 15, 2016 after a review of 144 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 Stryker GmbH devices

FDA 510(k) Submission Details - K161753

510(k) Number K161753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2016
Decision Date November 15, 2016
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 361
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K161753.
SALVATION External Fixation System
K162033 · Wright Medical · Mar 2017
Arrowhead Mini-Rail Fixator
K162032 · Arrowhead De, LLC · Feb 2017
Gexfix External Fixation
K160972 · Gexfix International Corp. · Dec 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
K161417 · Synthes (Usa), LLC · Nov 2016
Integra External Fixation System
K160830 · Ascension Orthopedics · Jul 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377 · Stryker GmbH · Apr 2016