EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
FDA 510(k) clearance K163497 · decided 2017-03-02
Clearance details
- K-number
- K163497
- Device name
- EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-13
- Decision date
- 2017-03-02
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- KWZ
- Device class
- 2
- Regulation number
- 888.3310
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, 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 |
|---|---|---|
| Mpact Constrained Liner (K241461) | Medacta International S.A. | 2025-07-31 |
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| Smith & Nephew, Inc. R3™ Constrained Liner (K162641) | Smith & Nephew, Inc. | 2017-06-19 |
| EXPRT Revision Hip System (K161610) | Encore Medical L.P. | 2016-11-09 |
| SMITH & NEPHEW R3 CONSTRAINED LINERS (K122139) | Smith & Nephew, Inc. | 2012-10-16 |
| SMITH & NEPHEW RJ CONSTRAINED LINERS (K111635) | Smith & Nephew, Inc. | 2011-09-09 |
| LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (K101730) | Zimmer, Inc. | 2010-12-03 |
| R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566) | Smith & Nephew, Inc. | 2009-03-03 |
| TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (K072121) | Zimmer, Inc. | 2008-01-07 |
| DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059) | DePuy Orthopaedics, Inc. | 2007-11-09 |
| EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS (K071676) | Exactech, Inc. | 2007-07-19 |
| TRILOGY LONGEVITY CONSTRAINED LINER (K071718) | Zimmer, Inc. | 2007-07-13 |
Recalls involving this device
No recalls on record reference this clearance.