Search Results
Found 1 results
510(k) Data Aggregation
K Number
K991052Device Name
FS 1000 KNEE SYSTEM
Manufacturer
RENAISSANCE INSTRUMENTS, LLC.
Date Cleared
1999-11-10
(225 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
RENAISSANCE INSTRUMENTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of varus, valgus, or post traumatic deformity;
- Correction or revision of unsuccessful osteotomy or arthrodesis; and
- Revision procedures where other treatments or devices have failed;
OR
- Treatment of fractures that are unmanageable using other techniques;
Device Description
Not Found
Ask a Question
Page 1 of 1