ARTICUL/EZE FEMORAL HEADS
FDA 510(k) clearance K980513 · decided 1998-04-14
Clearance details
- K-number
- K980513
- Device name
- ARTICUL/EZE FEMORAL HEADS
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-10
- Decision date
- 1998-04-14
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch DePuy Orthopaedics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CERAMAX® Ceramic Total Hip System (P070026/S128) | DePuy Orthopaedics, Inc. | 2026-07-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S127) | DePuy Orthopaedics, Inc. | 2026-06-03 |
| Ceramax® Ceramic Hip System (P070026/S125) | DePuy Orthopaedics, Inc. | 2026-04-29 |
| Ceramax Ceramic Hip System (P070026/S124) | DePuy Orthopaedics, Inc. | 2026-04-10 |
| Ceramax® Ceramic Total Hip System (P070026/S118) | DePuy Orthopaedics, Inc. | 2026-01-08 |
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |