Tracer Hip Pinning System
by De Medica Mfg., Inc. 510(k)
Active
510(k) K884406
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884406 | Date28 Nov 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tracer Hip Pinning System is a bone fixation device classified as a Nail, Fixation, Bone. It is designed to stabilize and secure fractured femoral heads or necks by providing internal fixation, ensuring proper alignment and promoting bone healing during orthopedic procedures.
This system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K884406). The system includes various sizes and configurations of fixation nails and pins, as referenced in the associated product codes. Proper handling and storage per manufacturer guidelines are required to maintain sterility and functionality.
Other devices from De Medica Mfg., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Tracer Hip Pinning System used for?
The Tracer Hip Pinning System is designed to stabilize and secure fractured femoral heads or necks during orthopedic surgery. By providing internal fixation, it ensures proper alignment of the bone fragments, which promotes effective healing and reduces complications from displacement.
How is the Tracer Hip Pinning System supplied?
The system is supplied as a sterile, single-use device. This ensures safety and consistency in surgical settings, as each component is intended for one-time use only to maintain sterility and prevent cross-contamination.
Are there multiple sizes or configurations available for the Tracer Hip Pinning System?
Yes, the Tracer Hip Pinning System includes various sizes and configurations of fixation nails and pins, as referenced by multiple product codes (e.g., 3002806685, 1000306431). These variations allow surgeons to select the appropriate components based on the patient’s anatomy and fracture specifics.
How should the Tracer Hip Pinning System be stored to maintain sterility?
The system must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage typically involves keeping the device in its original packaging, away from moisture, extreme temperatures, and direct sunlight, until ready for use in a sterile surgical environment.
Is the Tracer Hip Pinning System reusable, or is it intended for single-use only?
The Tracer Hip Pinning System is explicitly designed for single-use only. This classification ensures patient safety by preventing potential contamination or degradation from repeated sterilization processes, which could compromise the device’s integrity or sterility.