Poly Insert 20 Degree
by Dow Corning Wright 510(k)
Active
510(k) K920929
Overview
The Poly Insert 20 Degree is a semi-constrained metal cemented acetabular component for hip prostheses, designed to provide a 20-degree angled insert within the acetabular cup. This device is classified as a Class III prosthesis under FDA regulations and is intended for use in orthopedic hip replacement surgeries.
Supplied as a reusable medical device, the Poly Insert 20 Degree is intended for surgical use in controlled environments such as operating rooms. It is regulated under FDA 510(k) clearance (K920929) and falls under the product code JDL, with a regulatory classification of 888.3320. Sterility and packaging details are not specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920929 | Date5 May 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dow Corning Wright
Questions
What is the Poly Insert 20 Degree used for in orthopedic surgery?
The Poly Insert 20 Degree is a semi-constrained metal cemented acetabular component specifically designed for hip replacement surgeries. It provides a 20-degree angled insert within the acetabular cup to help position the prosthetic acetabulum correctly during total hip arthroplasty. This design is intended to improve stability and fit within the pelvis during the procedure.
Is the Poly Insert 20 Degree intended for single-use or reusable applications?
The Poly Insert 20 Degree is explicitly described as a reusable medical device. It is intended for surgical use in controlled environments like operating rooms, where it can be sterilized and reused for multiple procedures. This classification aligns with its design as a durable orthopedic implant component.
How is the regulatory status of the Poly Insert 20 Degree determined?
The Poly Insert 20 Degree is classified as a Class III prosthesis under FDA regulations and has obtained FDA 510(k) clearance with the designation K920929. It was determined to be substantially equivalent to a predicate device through a traditional review process by the Orthopedic (OR) Advisory Committee. The product code JDL and regulation number 888.3320 further categorize its regulatory pathway.
Are there different sizes or models of the Poly Insert 20 Degree available?
The provided data does not specify distinct sizes or models beyond the 20-degree angled insert design. However, the registration numbers and FEI numbers listed indicate multiple variants or lot identifiers, which may correspond to different production batches or configurations. For precise sizing or model variations, consulting the manufacturer’s catalog or technical documentation would be necessary.
What should be considered regarding storage and handling of the Poly Insert 20 Degree?
While the data does not detail sterility or specific packaging requirements, as a reusable medical device, the Poly Insert 20 Degree must be stored in a clean, dry environment to prevent contamination. Proper sterilization protocols must be followed before reuse, and handling should adhere to surgical instrument standards to maintain its integrity and functionality for subsequent procedures.