FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANATOMICAL TYPE KNEE SYSTEM
K Number: K922859
·
Decision Sep 23, 1993
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
18
Review Days
476
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
- ANATOMICAL TYPE KNEE SYSTEM
- K Number
- K922859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo Technology, Inc.
- Date Received
- June 4, 1992
- Decision Date
- September 23, 1993
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Osteo Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | Mar 9, 1994 | Substantially Equivalent for Some Indications |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | Jul 13, 1993 | Substantially Equivalent |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Jun 29, 1993 | Substantially Equivalent |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | Jun 17, 1993 | Substantially Equivalent |
| K922861 | BIOMETRIC SCREW FIXATION CUP | May 12, 1993 | Substantially Equivalent |
| K922870 | THREE SPIKE CUP | Apr 8, 1993 | Substantially Equivalent |
| K922682 | AMERICANA HIP PROTHESIS | Mar 16, 1993 | Substantially Equivalent |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | Mar 16, 1993 | Substantially Equivalent |
| K922871 | UNIFIT FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent |
| K922868 | THOMPSON TYPE HIP PROTHESIS | Feb 12, 1993 | Substantially Equivalent |