Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
An uncemented tibial hemi-knee resurfacing prosthesis is a surgically implanted device used to replace the tibial articular surface of the knee without the use of bone cement, relying on direct bone contact or ingrowth for fixation. It is classified as an FDA Class 2 device under 21 CFR 888.3590, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSH falls under the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- HSH
- Device Class
- FDA class 2
- Regulation Number
- 888.3590
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073233 | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | Jan 28, 2008 | Substantially Equivalent | Advanced Bio-Surfaces, Inc. |
| K053094 | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | Feb 06, 2006 | Substantially Equivalent | Advanced Bio-Surfaces, Inc. |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Dec 31, 2003 | Substantially Equivalent | Imaging Therapeutics, Inc. |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Nov 20, 2002 | Substantially Equivalent | Osteoimplant Technology, Inc. |
| K003269 | UNICONDYLAR INTERPOSITIONAL SPACER | Jan 04, 2001 | Substantially Equivalent | Sulzer Orthopedics, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.