IN MOTION LUMBAR ARTIFICIAL DISC

by DEPUY SPINE,INC

On Jan 11, 2011, the FDA received a filing from DEPUY SPINE,INC for a special(immediate track) of process change - other. On Feb 08, 2011, the OR review committee issued the following statement with the approval order:

APPROVAL FOR THE CHANGE IN TOLERANCE OF THE IMPLANT DIMENSIONS AND THE SUBSEQUENT INDEPENDENT INSPECTION OF THESE DIMENSIONS.

The review and decision took 28 days.

Trade Name IN MOTION LUMBAR ARTIFICIAL DISC
Generic Name LUMBAR ARTIFICIAL DISC
Applicant DEPUY SPINE,INC
P040006
Contact 325 PARAMOUNT DRIVE

RAYNHAM, MA, 02767
Product Code MJO

Previous Supplements

SupplementApprovals
S004
Sep 05, 2007
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT (NORMAL 180 DAY TRACK)
APPROVAL FOR: 1) ADDITIONAL ENDPLATES WITH LARGER FOOTPRINT, LATERAL PLACEMENT OF FIXATION TEETH, AND 1 MM OFFSET ARTICULATING SURFACE; 2) ADDITIONAL CORES WITH MODIFIED OUTER RIM; 3) MODIFIED SURGICAL INSTRUMENTS TO ACCOMMODATE MODIFIED DEVICE COMPONENTS; AND 4) MODIFIED SURGICAL TECHNIQUE.
S003
Dec 15, 2006
PROCESS CHANGE: MANUFACTURING (30-DAY NOTICE)
ADDITION TO THE DEPUY (IRELAND) LTD. FACILITY OF AN OPTIMAL IN-PROCESS CLEANLINE AND THREE NEW PIECES OF EQUIPMENT: A MAZAK INTEGREX MACHINING CENTRE, A SCHLICK BLAST UNIT AND A TRUMPF LASER-MARKING MACHINE.
S002
Mar 29, 2006
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL (NORMAL 180 DAY TRACK)
APPROVAL FOR 1) NEW ENDPLATES COATED WITH VACUUM PLASMA-SPRAYED PURE TITANIUM AND CALCIUM PHOSPHATE; 2) THREE NEW INTERMEDIATE ENDPLATE SIZES UTILIZING THIS SAME COATING; AND 3) VARIOUS SURGICAL INSTRUMENTS TO ACCOMMODATE THE PROPOSED NEW ENDPLATES.
S001
Jun 16, 2005
PROCESS CHANGE: STERILIZATION (NORMAL 180 DAY TRACK NO USER FEE)
APPROVAL FOR A MANUFACTURING SITES LOCATED AT DEPUY (IRELAND) LTD, CORK, IRELAND, FOR MANUFACTURING AND ISOTRON PLC, MARCUS CLOSE, BERKSHIRE, UNITED KINGDOM, FOR STERILIZATION.
Oct 26, 2004
APPROVAL FOR THE CHARITE ARTIFICIAL DISC. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN 3 MM OF SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE CHARITE ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE CHARITE ARTIFICIAL DISC.