Cleared Special

K010529 - TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

K010529 is the FDA 510(k) clearance for TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Special 510(k) pathway after a 63-day FDA review.

K010529 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
63d
Days
Class 2
Risk

K010529 is an FDA 510(k) clearance for the TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 63 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.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K010529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 23, 2001
Decision Date April 27, 2001
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 448
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K010529.
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · DePuy Orthopaedics, Inc. · Jun 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · Howmedica Osteonics Corp. · Jun 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · Exactech, Inc. · May 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · Howmedica Osteonics Corp. · Apr 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · Howmedica Osteonics Corp. · Mar 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · Corin USA · Feb 2001