Patient Specific Manual Orthopedic Stereotaxic System
The Patient Specific Manual Orthopedic Stereotaxic System (product code OSF) is a device intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy during total hip arthroplasty. It enables precise, patient-specific cup placement in hip replacement surgery without electronic navigation. As an FDA Class 2 device under regulation 882.4560, it requires 510(k) premarket clearance, falls within the Neurology specialty by regulation, and is reviewed by the Orthopedic panel. The device is not an implant itself and is not life-sustaining.
Basic Information
- Product Code
- OSF
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233315 | HipXpert and HipInsight System | Aug 08, 2024 | Substantially Equivalent | Surgical Planning Associates, Inc. |
| K200384 | HipXpert 3D Display and Anchoring Application | Jan 28, 2021 | Substantially Equivalent | Surgical Planning Associates, Inc. |
| K093491 | HIP SEXTANT INSTRUMENT SYSTEM | Dec 09, 2010 | Substantially Equivalent | Surgical Planning Associates |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.