Cleared Traditional

K031155 - OSTEOMED SUBTALAR IMPLANT SYSTEM

K031155 is an FDA 510(k) clearance for OSTEOMED SUBTALAR IMPLANT SYSTEM, manufactured by Osteomed LP. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K031155 · Osteomed LP · Orthopedic device
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Aug 2003
Decision
133d
Days
Class 2
Risk

K031155 is an FDA 510(k) clearance for the OSTEOMED SUBTALAR IMPLANT SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 133 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. 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 Osteomed LP devices

FDA 510(k) Submission Details - K031155

510(k) Number K031155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2003
Decision Date August 22, 2003
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 966
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K031155.
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · Arthrotek, Inc. · Oct 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · Arthrex, Inc. · Sep 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · Arthrocare Corp. · Sep 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003