HSA · registration DE0510607Synthes KINCISE™ Surgical Automated System
SingaporeOrthopaedicsClass BSynthes GmbH
Official record identity
- Registration number
- DE0510607
- Model name
- KINCISE™ System Automated Surgical Handpiece V2; KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long; KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor; KINCISE™ System Primary Hip PINNACLE™ Inclination Guide; KINCISE™ System Primary Hip PINNACLE™ Version Guide; KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Short; KINCISE™ System Primary Hip Femoral Broach Adapter - Curved; KINCISE™ System Primary Hip Femoral Broach Adapter - Straight; KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ Stem Impactor - Offset; KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Offset; KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight; KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Straight; KINCISE™ System Primary Hip Femoral Head Impactor - Shaft; EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Long; EMPHASYS™ KINCISE™ System Offset Shell/Liner Impactor; EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Short; EMPHASYS™ KINCISE™ System Stem Impactor - Straight; EMPHASYS™ KINCISE™ System Stem Impactor - Offset; KINCISE™ System Primary Hip Threaded Femoral STEM Extractor - M6 X 1mm; KINCISE™ System ATTUNE™ Revision Broach Adapter
- Model identifier
- 2000-00-001; 200002002; 200002003; 200002005; 200002006; 200002012; 200002101; 200002102; 200002202; 200002203; 200002212; 200002213; 200002301; 200003001; 200003002; 200003012; 200003201; 200003202; 200004012; 200007008
- Registration date
- April 19, 2025
- Source update date
- October 17, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Synthes GmbH
- Registrant / registration holder
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Official description
Intended to impact bone for bone preparation, implant assembly and extraction, and implant positioning during orthopaedic surgeries.
Additional source fields
- Product owner address
- Eimattstrasse 3, 4436 Oberdorf, Switzerland
- Registrant address
- 2 SCIENCE PARK DRIVE, #07-13, ASCENT, Singapore 118222
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.