Definition: The Acetabular Cup Orientation System Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Orientation Of Acetabular Cup Components Used With Total Hip Arthroplasty. The Device Utilizes Anatomic Landmarks Of The Pelvis Tha
| Device Type ID | 4687 |
| Device Name | Acetabular Cup Orientation System |
| Physical State | A Patient-matched Acetabular Guide, Made Of Polymeric Material And With A Patient-matched Surface That Is Congruent To The Mating Acetabular Surface. May Be Manufactured Through An Additive Manufacturing Process. |
| Technical Method | The Device Consists Of A Software Component That Generates A Pre-operative Plan Based On The Medical Imaging Data And A Hardware Component, The Patient-matched Guide That Is Positioned Onto/within The Acetabulum By Mating The Patient-specific Contact |
| Target Area | Acetabulum |
| Regulation Description | Hip Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4687 |
| Device | Acetabular Cup Orientation System |
| Product Code | PLW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hip Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3350 [🔎] |