AVON PATELLO-FEMORAL JOINT PROSTHESIS— 510(k) K051948
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K051948 for AVON PATELLO-FEMORAL JOINT PROSTHESIS, Substantially Equivalent on 2005-10-21. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code KRR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code KRR
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view all- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Recalls naming K051948
K-number listed on FDA's recall record- Z-0893-2024 — SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
- Z-0894-2024 — SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
- Z-0895-2024 — SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
- Z-0896-2024 — SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
- Z-0897-2024 — SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
- Z-0900-2024 — Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051948.
Data sourced from openFDA. This site is unofficial and independent of the FDA.