ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
FDA 510(k) clearance K965002 · decided 1997-06-27
Clearance details
- K-number
- K965002
- Device name
- ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND
- Applicant
- Encore Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-16
- Decision date
- 1997-06-27
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- LZO
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Encore Orthopedics
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 |
|---|---|---|
| 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.