TOTAL HIP, LORD MADREPORIC
FDA 510(k) clearance K780330 · decided 1978-05-12
Clearance details
- K-number
- K780330
- Device name
- TOTAL HIP, LORD MADREPORIC
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-28
- Decision date
- 1978-05-12
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Corp.
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.
| Record | Firm | Date |
|---|---|---|
| PROFEMUR Z REVISION HIP STEM (K122778) | Wrightmedicaltechnologyinc | 2012-10-11 |
| DYNASTY BIOFOAM SHELL (K121544) | Wrightmedicaltechnologyinc | 2012-07-30 |
| METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271) | Biomet Manufacturing, Inc. | 2012-05-18 |
| CONSERVE THIN SHELL (K113322) | Wrightmedicaltechnologyinc | 2012-02-03 |
| PRESERVE HIP STEM (K112080) | Wrightmedicaltechnologyinc | 2011-12-28 |
| PROFEMUR GLADIATOR HA HIP STEM (K112150) | Wrightmedicaltechnologyinc | 2011-11-23 |
| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
| GLADIATOR HIP STEM (K111910) | Wrightmedicaltechnologyinc | 2011-10-14 |
| CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836) | Zimmer GmbH | 2011-10-07 |
| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |