Prosthesis, Hip, Semi-Constrained, Composite/Metal
The Semi-Constrained Hip Prosthesis (Composite/Metal) is a surgically implanted orthopedic device used in total or partial hip arthroplasty to replace a diseased or damaged hip joint, utilizing a composite and metal construction to restore mobility and relieve pain. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KMC and the applicable regulation is 21 CFR 888.3340 in the Orthopedic specialty. This device is an implant.
Basic Information
- Product Code
- KMC
- Device Class
- FDA class 2
- Regulation Number
- 888.3340
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K936044 | ENHANCED MODULAR AUSTIN MOORE HIP | Apr 26, 1994 | Substantially Equivalent | ZIMMER, INC. |
| K853524 | APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT | Nov 22, 1985 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K853259 | MALLORY/HEAD TOTAL HIP SYSTEM | Nov 01, 1985 | Substantially Equivalent for Some Indications | BIOMET, INC. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.