FDA product code HSH: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
HSH is the FDA product code for prosthesis, knee, hemi-, tibial, resurfacing (uncemented). It is a Class II device, regulated under 21 CFR 888.3590 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under HSH, from 4 different applicants. The average 510(k) review took 84 days (median 85).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) |
| Device class | Class II |
| Regulation | 21 CFR 888.3590 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HSH clearance
Top HSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Bio-Surfaces, Inc. | 2 | 2008-01-28 |
| Imaging Therapeutics, Inc. | 1 | 2003-12-31 |
| Osteoimplant Technology, Inc. | 1 | 2002-11-20 |
| Sulzer Orthopedics, Inc. | 1 | 2001-01-04 |
Most recent HSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073233 | Advanced Bio-Surfaces, Inc. | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS | 2008-01-28 | 74 |
| K053094 | Advanced Bio-Surfaces, Inc. | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 | 2006-02-06 | 95 |
| K033242 | Imaging Therapeutics, Inc. | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | 2003-12-31 | 85 |
| K022779 | Osteoimplant Technology, Inc. | OTI UNICONDULAR INTERPOSITIONAL SPACER | 2002-11-20 | 90 |
| K003269 | Sulzer Orthopedics, Inc. | UNICONDYLAR INTERPOSITIONAL SPACER | 2001-01-04 | 78 |
Recalls for HSH devices
openFDA lists no recalls for product code HSH.
Frequently asked questions
What is FDA product code HSH?
HSH is the FDA product code for prosthesis, knee, hemi-, tibial, resurfacing (uncemented). It is a Class II device, regulated under 21 CFR 888.3590 and reviewed by the Orthopedic panel.
What device class is HSH?
Class II, regulation 21 CFR 888.3590. Typical premarket route: 510(k).
How long does a 510(k) take for product code HSH?
Across 5 cleared submissions the average was 84 days from receipt to decision (median 85).
Which companies have the most HSH clearances?
Advanced Bio-Surfaces, Inc. (2); Imaging Therapeutics, Inc. (1); Osteoimplant Technology, Inc. (1); Sulzer Orthopedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HSH
- Run a recall and safety report across every HSH manufacturer
- Watch product code HSH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times