Product code KXA— Orthopedic
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
- Classification name
- Prosthesis, Hip, Femoral, Resurfacing
- Device class
- Class 2
- Regulation
- 21 CFR 888.3400
- Advisory panel
- Orthopedic
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code KXA
FDA has cleared devices under product code KXA between 1977 and 2021, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2010
- 2008
- 2007
- 2006
- 2005
- 2003
- 2002
- 2000
- 1998
- 1995
- 1994
- 1991
- 1989
- 1988
Top applicants under product code KXA
Adverse events under product code KXA
product code KXA- Injury
- 324
- Total
- 324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KXA
- K201219 — Biocore9 Femoral Head Resurfacing Component
- K092198 — CORMET CEMENTLESS RESURFACING FEMORAL HEAD
- K082673 — CONSERVE PRESSFIT FEMORAL COMPONENT
- K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
- K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
- K062960 — CONSERVE FEMORAL RESURFACING COMPONENT
- K043542 — BIOPRO TARA FEMORAL RESURFACING COMPONENT
- K032659 — DEPUY ASR RESURFACING FEMORAL HEADS
- K023188 — PRESS-FIT HEAD RESURFACING DEVICE
- K021549 — CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
- K021799 — CEMENTED FEMORAL HEAD RESURFING DEVICE
- K994153 — CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
- K983452 — NELSON RESURFACING HEAD
- K950998 — MODUILAR UNIPOLAR
- K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT
- K904870 — MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
- K894604 — BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
- K892398 — BIPOLAR HIP SYSTEM
- K883212 — LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
- K842233 — NEW JERSEY FEMORAL RESURFACING COMPONENT
- K792200 — TILLMAN HIP RESURFACING REPLACEMT PROS.
- K781490 — TILLMAN HIPSURFACE REPLACEMENT
- K761324 — RESURFACE PROSTHESES FOR HIP JOINT
Data sourced from openFDA. This site is unofficial and independent of the FDA.