PMA P810020S004

Device: PALACOS E-FLOW (OSTEOPAL) BONE CEMENT
Applicant: Smith & Nephew Richards, Inc.
PMA number: P810020
Supplement: S004
Product code: LOD
Decision date: 1998-07-30
Generic name: BONE CEMENT
Approval order statement: Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.

Current openFDA PMA Record#

Device: PALACOS E-FLOW (OSTEOPAL) BONE CEMENT
Applicant: Smith & Nephew Richards, Inc.
PMA number: P810020
Supplement: S004
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1998-07-30
Decision code: APPR
Date received: 1995-07-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.