SMARTMIX PRE-FILLED MIXING SYSTEM
FDA 510(k) clearance K042591 · decided 2004-10-22
Clearance details
- K-number
- K042591
- Device name
- SMARTMIX PRE-FILLED MIXING SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-23
- Decision date
- 2004-10-22
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KIH
- Device class
- 1
- Regulation number
- 888.4200
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| P.F.C. CEMENT PRESSURIZING SYSTEM (K943906) | Johnson & Johnson Professionals, Inc. | 1994-12-21 |
| CMW CEMENT PRESSURISATION SYSTEM (K897134) | Dentsply Intl. | 1990-03-02 |
| ORTHOPEADIC CEMENT DELIVERY SYSTEM (K851881) | Dentsply Intl. | 1985-06-13 |
| PRESSURIZING/SCAVENGING ACRYLIC CEMENT (K840046) | Precision Medical Devices, Inc. | 1984-02-09 |
| BRIGHAM TIBIAL CEMENT PRESSURIZER (K833675) | Howmedica Corp. | 1983-12-12 |
| HOWMEDICA FEMORAL PRESSURING SEAL (K811317) | Howmedica Corp. | 1981-05-29 |
| OH-HARRIS (K801388) | Johnson & Johnson Professionals, Inc. | 1980-07-28 |
| GUN, EXETER CEMENT (K790275) | Howmedica Corp. | 1979-02-21 |
| GUN, CEMENT (K781955) | Depuy, Inc. | 1978-12-04 |
| BONE CEMENT APPLICATOR (K780266) | Zimmer, Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |