BG Proximal Femur

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K790274 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What types of patients is the BG Proximal Femur designed to help, and how does it restore function?

  The BG Proximal Femur is intended for patients suffering from degenerative joint disease or hip fractures, where the natural femoral head and acetabulum have been damaged. It replaces these components in total hip arthroplasty to restore mobility and alleviate chronic pain by providing a stable, semi-constrained metal acetabular implant that mimics the natural hip joint’s movement.

• Is the BG Proximal Femur reusable or single-use, and how should it be handled in the operating room?

  The BG Proximal Femur is designed as a reusable surgical implant, meaning it is intended for multiple uses after proper sterilization. Like all orthopedic implants, it must be handled in sterile conditions within the operating room and sterilized according to standard orthopedic implant protocols to ensure safety and prevent contamination.

• What regulatory pathway was followed for FDA clearance, and what does the product code JDL indicate?

  The BG Proximal Femur received FDA clearance through a 510(k) submission (K790274), classified as a Class III medical device under product code JDL, which corresponds to ‘Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component).’ The clearance was granted as *Substantially Equivalent (SESE)* to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously approved product.

• Are there multiple sizes or models available for the BG Proximal Femur, and how would a surgeon select the appropriate one?

  The BG Proximal Femur comes in multiple sizes and models, as indicated by the extensive list of FEI numbers (e.g., 3020282716, 3007923096) in the data. These identifiers correspond to specific implant dimensions and orientations to accommodate varying patient anatomies. Surgeons would select the appropriate size based on preoperative imaging and intraoperative assessment to ensure proper fit and function during total hip arthroplasty.