510(k) Report

Devices descending from K900003

10 later devices reach System Ten Model 100 Surgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031280Ultra-Drive 3Biomet, Inc.200343
+1K961725Oscar Orthosonics System for Cemented Arthroplasty RevisionC.L. Mcintosh & Assoc., Inc.19968—
+2K083830Oscar Bone ResectorOrthosonics, Ltd.20091—
+2K051053Oscar, Model OE3000DBOrthosonics, Ltd.20053—
+2K021502Oscar, Model OE3000Orthosonics, Ltd.20027—
+3K093805OSCAR 3Orthosonics, Ltd.20100—
+3K072961Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)Sra Developments, Ltd.20070—
+3K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd.20072—
+4K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd.20151—
+5K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd.20220—