Cleared Traditional

K203568 - Hoffmann LRF System

K203568 is the FDA 510(k) clearance for Hoffmann LRF System by Stryker GmbH. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K203568 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
56d
Days
Class 2
Risk

K203568 is an FDA 510(k) clearance for the Hoffmann 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 February 1, 2021 after a review of 56 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 Stryker GmbH devices

Submission Details

510(k) Number K203568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2020
Decision Date February 01, 2021
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K203568.
SMART Taylor Spatial Frame
K210953 · Smith & Nephew, Inc. · Jul 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313 · Synthes USA Products, LLC · May 2021
OIC External Fixation System
K211112 · Orthopaedic Implant Company · May 2021
Sequel External Fixation Device
K202833 · Sequel Medical, Inc. · Jan 2021
AutoStrut G2
K202810 · Orthospin, Ltd. · Jan 2021
Bfix Orthopedic External Fixator Systems
K200491 · Aike (Shanghai) Medical Instrument Co., Ltd. · Jan 2021