JDK · Prosthesis, Hip, Cement Restrictor
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | JDK |
|---|---|
| Device Name | Prosthesis, Hip, Cement Restrictor |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 54)
Showing 20 most recent of 54 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210062 | Mectaplug PE II | Medacta International S.A. | Apr 8, 2021 | SESE |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Kinetikos Medical, Inc. | Oct 5, 2006 | SESU |
| K061698 | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | Life Spine | Jul 12, 2006 | SESE |
| K060247 | LIFE SPINE CEMENT RESTRICTOR | Life Spine | May 11, 2006 | SESU |
| K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM | Spinal USA | Mar 16, 2006 | SESE |
| K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR | Interbody Innovations, Llp | Dec 6, 2005 | SESU |
| K051836 | SKELITE RESORBABLE CEMENT RESTRICTOR | Millenium Biologix, Inc. | Nov 21, 2005 | SESU |
| K051607 | NOVASPINE CEMENT RESTRICTOR NSCR | Novaspine, LLC | Oct 7, 2005 | SESE |
| K052367 | SCIENT'X CEMENT RESTRICTOR | Scient'X | Oct 5, 2005 | SESU |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | Jun 17, 2005 | SESU |
| K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 | Amedica Corp. | Apr 15, 2005 | SESE |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | Innovasis, Inc. | Jul 22, 2004 | SESU |
| K033953 | OPTIMESH 500E CEMENT RESTRICTOR | Spineology, Inc. | Jul 6, 2004 | SESU |
| K040276 | QUANTUM CEMENT RESTRICTOR | Quantum Orthopedics | Apr 30, 2004 | SESE |
| K030871 | FIDJI LARGE CEMENT RESTRICTOR | Spine Next SA | Dec 22, 2003 | SESU |
| K030767 | FIDJI SMALL CEMENT RESTRICTOR | Spine Next SA | Dec 22, 2003 | SESU |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | Implex Corp. | Nov 19, 2003 | SESE |
| K032180 | NUVASIVE CEMENT RESTRICTOR | Nuvasive, Inc. | Oct 7, 2003 | SESU |
| K031318 | TRAXIS CEMENT RESTRICTOR | Spinal Concepts, Inc. | Aug 22, 2003 | SESU |
| K032095 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | Aug 8, 2003 | SESE |
Top Applicants
- Osteonics Corp. — 6 clearances
- Spinal Concepts, Inc. — 5 clearances
- Medtronic Sofamor Danek, Inc. — 5 clearances
- Theken Surgical,Llc — 2 clearances
- Spine Next SA — 2 clearances
