FDA 510(k)
FDA class 3
Substantially Equivalent for Some Indications
🇺🇸 United States
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K Number: K882675
·
Decision Aug 19, 1988
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
33
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ATH METAL:UHMWPE TOTAL HIP SYSTEM
- K Number
- K882675
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Kinamed, Inc.
- Date Received
- June 28, 1988
- Decision Date
- August 19, 1988
- Product Code
- KWA
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
PROFEMUR Z REVISION HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
DYNASTY BIOFOAM SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
FDA 510(k)
FDA Class 3
·Orthopedic
CONSERVE THIN SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Other Clearances by Kinamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | Apr 5, 2013 | Substantially Equivalent |
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | Nov 9, 2007 | Substantially Equivalent |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | May 24, 2005 | Substantially Equivalent |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Mar 11, 2004 | Substantially Equivalent |
| K032950 | GEM INSET PATELLAR COMPONENT | Dec 19, 2003 | Substantially Equivalent |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Oct 21, 2003 | Substantially Equivalent |
| K020764 | NAVIPRO | Jun 3, 2002 | Substantially Equivalent |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | May 21, 2002 | Substantially Equivalent |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | May 17, 2001 | Substantially Equivalent |
| K003347 | ORTHOPILOT | Feb 23, 2001 | Substantially Equivalent |