CDH HIP STEM
FDA 510(k) clearance K945096 · decided 1995-01-19
Clearance details
- K-number
- K945096
- Device name
- CDH HIP STEM
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-10-17
- Decision date
- 1995-01-19
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- LZO
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, 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 |
|---|---|---|
| MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| Z1 Hip System (K260831) | Zimmer, Inc. | 2026-06-16 |
| Avenir® Müller Stem; Avenir Complete™ Hip System (K260182) | Zimmer, Inc. | 2026-04-27 |
| implantcast Packaging System Update (K260037) | Implantcast GmbH | 2026-03-30 |
| implaFit® short stems (K252401) | Implantcast GmbH | 2026-03-12 |
| Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171) | Maxx Orthopedics, Inc. | 2026-01-15 |
| Coated hip implants (K250450) | Medacta International S.A. | 2025-09-19 |
| Longboard Revision Hip Stem (K243021) | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| Z1 Hip System (K251906) | Zimmer, Inc. | 2025-07-18 |
| RECLAIM Monobloc Revision Femoral Stem (K251292) | Depuy Ireland UC | 2025-05-23 |
| MobileLink Acetabular Cup System - inhouse coatings (K243927) | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| NEXUS® Hip Stem (K250444) | Microport Orthopedics, Inc. | 2025-05-15 |
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 |