Cleared Traditional

K990345 - RABEA DEVICE

K990345 is an FDA 510(k) clearance for RABEA DEVICE, manufactured by Signus Medizintechnik GmbH. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K990345 · Signus Medizintechnik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
176d
Days
Class 2
Risk

K990345 is an FDA 510(k) clearance for the RABEA DEVICE, MODEL PXXXXXX. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Signus Medizintechnik GmbH (Shorewood, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 176 days - an extended review cycle.

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 Signus Medizintechnik GmbH devices

FDA 510(k) Submission Details - K990345

510(k) Number K990345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 04, 1999
Decision Date July 30, 1999
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
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 34
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K990345.
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · Medtronic Sofamor Danek, Inc. · Aug 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · Medtronic Sofamor Danek, Inc. · Jul 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · Medtronic Sofamor Danek, Inc. · Feb 2001
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
BONE CEMENT RESTRICTOR
K926216 · Biodynamic Technologies, Inc. · Mar 1994
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992