Hi-Nek Total Hip
FDA 510(k) K873632 · Orthopedic Systems, Inc.
510(k) numberK873632
Submission
- Device name
- Hi-Nek Total Hip
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- September 8, 1987
- Decision date
- December 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
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| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Hi-Nek Total Hip cleared by the FDA?
Hi-Nek Total Hip (K873632) received a 510(k) decision of Substantially Equivalent on December 7, 1987, 90 days after the submission was received.
What is the product code of K873632?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.