Cleared Traditional

NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM (K011118) - FDA 510(k) Clearance

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

K011118 · Osteomedics · Orthopedic device
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Jul 2001
Decision
99d
Days
Class 2
Risk

K011118 is an FDA 510(k) clearance for the NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteomedics (Paramus, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 99 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 Osteomedics devices

Submission Details

510(k) Number K011118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2001
Decision Date July 20, 2001
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K011118.
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · Synthes (Usa) · Aug 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · Synthes (Usa) · Jul 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · Synthes (Usa) · Jul 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · Synthes (Usa) · Jul 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · Synthes (Usa) · May 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · Biomet, Inc. · May 2001