Cleared Special

K102885 - HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

K102885 is an FDA 510(k) clearance for HOFFMANN II EXTERNAL FIXATION SYSTEM LI..., manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Special 510(k) pathway after a 106-day FDA review.

K102885 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
106d
Days
Class 2
Risk

K102885 is an FDA 510(k) clearance for the HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-.... Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Stryker Corp. (Mahwah, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102885

510(k) Number K102885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date January 14, 2011
Days to Decision 106 days
Submission Type Special
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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 84
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K102885.
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K072432 · Hand Biomechanics Lab, Inc. · Jan 2008
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476 · Synthes (Usa) · Aug 2007
K102885 · HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
Download PDF FDA Summary Stryker Corp.