Cleared Traditional

K063298 - OSTEOMED HEADLESS CANNULATED SCREW SYSTEM

K063298 is an FDA 510(k) clearance for OSTEOMED HEADLESS CANNULATED SCREW 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 121-day FDA review.

K063298 · Osteomed LP · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
121d
Days
Class 2
Risk

K063298 is an FDA 510(k) clearance for the OSTEOMED HEADLESS CANNULATED SCREW 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 March 2, 2007 after a review of 121 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 - K063298

510(k) Number K063298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date March 02, 2007
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 967
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063298.
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525 · Wrightmedicaltechnologyinc · Mar 2007
MEMOMETAL FIXOS SCREWS
K070039 · Memometal Technologies · Mar 2007
UNITY ALPHA SYSTEM
K062820 · Bonutti Research, Inc. · Mar 2007
MATRYX INTERFERENCE SCREW, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5
K063588 · Conmed Linvatec Biomaterials · Mar 2007
GSO BONE FIXATION FASTENERS
K063589 · Gold Standard Orthopaedics, LLC · Jan 2007
ARC SURGICAL BONE REDUCTION SCREW
K063244 · Arc Surgical, LLC · Dec 2006