Proforma Hip System
510(k) K883941
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883941 | Date30 Nov 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Proforma Hip System is a prosthetic hip replacement device designed to restore function and mobility in patients with degenerative joint disease, fractures, or other conditions requiring total hip arthroplasty. It consists of modular components, including femoral and acetabular implants, intended to replicate the natural anatomy and biomechanics of the hip joint. The system is classified under the FDA’s product code JDI as a Prosthesis, Hip, and is intended for use in orthopedic surgical procedures.
This device is supplied as a sterile, single-use implant intended for surgical implantation by qualified orthopedic surgeons in hospital operating rooms. It is regulated under FDA 510(k) clearance (K883941) and falls under the Orthopedic advisory committee classification. The system is not MRI-safe and must be handled and stored according to manufacturer instructions to maintain sterility and integrity. No additional regulatory approvals beyond the 510(k) clearance are stated in the available data.
Other devices from Orthomet, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Proforma Hip System used for?
The Proforma Hip System is designed for total hip arthroplasty, replacing damaged or diseased hip joints in patients suffering from degenerative joint disease, fractures, or other conditions causing severe mobility impairment. Its modular components—femoral and acetabular implants—are engineered to replicate the natural hip joint’s anatomy and biomechanics, restoring function and stability.
How is the Proforma Hip System supplied and prepared for surgery?
The Proforma Hip System is supplied as a sterile, single-use implant. It must be handled and stored strictly according to Orthomet’s instructions to preserve sterility and structural integrity. The system is not intended for reuse and is intended exclusively for surgical implantation by qualified orthopedic surgeons in hospital operating rooms.
Is the Proforma Hip System safe for MRI procedures?
No, the Proforma Hip System is explicitly not MRI-safe. Patients with this implant should avoid MRI scans, as the device may generate heat or cause distortion in magnetic fields, posing safety risks. Always confirm imaging protocols with radiology staff before any MRI procedure.
What regulatory approval does the Proforma Hip System hold?
The Proforma Hip System holds FDA 510(k) clearance (K883941) under the Orthopedic advisory committee classification. This clearance confirms it meets FDA standards for safety and effectiveness as a prosthesis for total hip replacement, classified under product code JDI. No additional regulatory approvals beyond this are stated.
Are there different sizes or models available for the Proforma Hip System?
The specifications provided do not detail specific size ranges or model variants of the Proforma Hip System. However, as a modular prosthesis, it likely offers multiple component sizes to accommodate varying patient anatomies. For precise sizing options, refer to Orthomet’s surgical technique guide or consult their technical support team.