Zimmer Sesamoid™ System (OS Unicondylar Knee Replacement)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ZIMMER PTE. LTD.

Class:

Class B medical device

Manufactured by:

Zimmer CAS

Therapeutic area:

Orthopaedics

Therapeutic indications:

Computer Assisted Surgery system intended to assist in positioning orthopedic Unicondylar Knee Replacement implant and instrument components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images, or relative to their alignment axes as based on anatomical landmarks that are identified intra-operatively by the user.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Sterile Medical Device System or Procedure Pack; Models: CAS UNI KNEE INST SUB KT - KT800001004, CAS SESMD PLSTY TRANSPT SET - KT800007009, CAS CALIBRATION STAR HOLDER - 20800001001, CAS U-TKA VALIDATION TOOL - 20800001006, CAS U-TKA DIST POST COND DIG - 20800001017, CAS UNV OFFSET PADDLE 1MM - 20800001028, CAS UNIV OFFSET PADDLE 1.27MM - 20800001029, CAS UNV OFFSET PADDLE MAGNET - 20800001030, CAS VALIDATION PADDLE - 20800001031, CAS 2 PIN BONE REF FEMUR TS3 - 20800001033, CAS OFS 2 PIN REF RT TIBIA SZ6 - 20800001035, CAS OFS 2 PIN REF LT TIBIA SZ6 - 20800001036, CAS WING SCREW M5X10 - 20800001037, CAS UTKR LOWER INSERT - 20800001038, CAS UTKR UPPER 1/2 INSERT - 20800001039, CAS KNEE UNIV NAMEPLATE - 20800001051, CAS SET SCREW M8 X 1.25MM - 20800002021, CAS SCRDRVR 3.5MM W/CONCTR M12 - 20800002022, CAS REGISTER POINTER - 20800007001, CAS MAIN CASE - 20800007002, CAS LID - 20800007003, CAS NAVITRACKER PLIERS - 20800007005, CAS COMP/CAMERA TRANSPT BOX - 20800007030, CAS SESMD PLASTY TRANSPT BAG - 20800007033, CAS SESMD PLTY TRANSPT BAG CVR - 20800007034, CAS SESMD PLASTY CAMERA P7 - 20800007035, CAS SESMD PLSTY SGL STANDN P7 - 20800007036, CAS NAVITRACK KIT A-KNEE/SPINE - 20800000007, CAS FIX PIN FLTD 3.2D X 150MM - 20800000001, CAS FIX PIN FLTD 3.2D X 80MM - 20800000002, CAS FIX PIN FLTD 3.2D X 80MMx12 - 20800000003, CAS FIX PIN FLTD 3.2DX150MM-12 - 20800000004, Sesamoid Plasty CPU Kit AAEON - 20800007064, CAS SESMD PLASTY COMPUTER - 20800007046

Authorization date:

2012-03-07