DePuy aSphere M-Spec Head
510(k) K082585
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082585 | Date4 Dec 2008 | StatusActive |
Official records
- FDA 510(k) database K082585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWA
- Device class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The DePuy aSphere M-Spec Head is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for modular use in total hip arthroplasty. This femoral head component is intended to articulate with acetabular inserts and cups while attaching to DePuy femoral stems, providing a semi-constrained interface for hip joint replacement.
The device is supplied as a reusable, modular component for surgical use in orthopedic settings. It is not sterile at time of shipment and requires sterilization prior to use, adhering to standard orthopedic implant protocols. The aSphere M-Spec Head is classified as a Class III device under FDA regulations (KWA product code) and holds an FDA 510(k) clearance (K082585) for substantial equivalence. Multiple reference codes (e.g., 1818910, 3002807113) identify specific variants within the product line.