Cleared Traditional

K030871 - FIDJI LARGE CEMENT RESTRICTOR

K030871 is an FDA 510(k) clearance for FIDJI LARGE CEMENT RESTRICTOR, manufactured by Spine Next SA. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K030871 · Spine Next SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
278d
Days
Class 2
Risk

K030871 is an FDA 510(k) clearance for the FIDJI LARGE CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Spine Next SA (Queenstown, US). The FDA issued a Cleared decision on December 22, 2003 after a review of 278 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 Spine Next SA devices

FDA 510(k) Submission Details - K030871

510(k) Number K030871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 19, 2003
Decision Date December 22, 2003
Days to Decision 278 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
156d slower than avg
Panel avg: 122d · This submission: 278d
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 38
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K030871.
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · Amedica Corp. · Apr 2005
PEEK CEMENT RESTRICTOR X-BOX
K041583 · Innovasis, Inc. · Jul 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · Spineology, Inc. · Jul 2004
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp. · Nov 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · Nuvasive, Inc. · Oct 2003
TRAXIS CEMENT RESTRICTOR
K031318 · Spinal Concepts, Inc. · Aug 2003