Cleared Traditional

K030608 - OTI BONE CEMENT PLUG

K030608 is an FDA 510(k) clearance for OTI BONE CEMENT PLUG, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K030608 · Osteoimplant Technology, Inc. · Orthopedic device
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Jun 2003
Decision
106d
Days
Class 2
Risk

K030608 is an FDA 510(k) clearance for the OTI BONE CEMENT PLUG. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on June 12, 2003 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 878.3300 - 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K030608

510(k) Number K030608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 26, 2003
Decision Date June 12, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
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
Predicate-based equivalence. No clinical trials required.

JDK Device Classification - Class 2, Special Controls

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 36
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K030608.
TRAXIS CEMENT RESTRICTOR
K031318 · Spinal Concepts, Inc. · Aug 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · Interpore Cross Intl. · Aug 2003
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K031837 · Spinal Concepts, Inc. · Jul 2003
INTERPORE CROSS CEMENT RESTRICTOR
K023908 · Interpore Cross Intl. · May 2003
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · Spinal Concepts, Inc. · Nov 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · Exactech, Inc. · Aug 2002