Cleared Traditional

N-FORCE FIXATION SYSTEM (K102528) - FDA 510(k) Clearance

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

K102528 · Innovision, Inc. · Orthopedic device
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Jul 2011
Decision
328d
Days
Class 2
Risk

K102528 is an FDA 510(k) clearance for the N-FORCE FIXATION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Innovision, Inc. (Washington, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 Innovision, Inc. devices

Submission Details

510(k) Number K102528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date July 28, 2011
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K102528.
ORTHOLOC(TM) BONE SCREWS
K112772 · Wrightmedicaltechnologyinc · Oct 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · Zimmer, Inc. · Oct 2011
MICROSUTURE ANCHORS
K112237 · Arthrex, Inc. · Sep 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa) · Jul 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011