Cleared Special

K002324 - MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA

K002324 is an FDA 510(k) clearance for MODIFIED TO MODULAR FR SEVERE BONE LOSS..., manufactured by Sulzermedica. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 24-day FDA review.

K002324 · Sulzermedica · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
24d
Days
Class 2
Risk

K002324 is an FDA 510(k) clearance for the MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Sulzermedica (Austin, US). The FDA issued a Cleared decision on August 24, 2000 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002324

510(k) Number K002324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date August 24, 2000
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 550
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K002324.
DEPUY C-STEM SYSTEM
K003421 · DePuy Orthopaedics, Inc. · Dec 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · Biomet, Inc. · Nov 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · Implex Corp. · Aug 2000
BAUMER FEMORAL HEAD
K001571 · Baumer, S.A · Aug 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · Biomet, Inc. · Jul 2000
TI-MAX PROTRUSIO CAGE
K001376 · Biomet, Inc. · Jul 2000
K002324 · MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
Download PDF FDA Summary Sulzermedica