Atlas FDA

REFLECTION CONSTRAINED LINER

FDA 510(k) clearance K021803 · decided 2002-12-19

Clearance details

K-number
K021803
Device name
REFLECTION CONSTRAINED LINER
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2002-06-03
Decision date
2002-12-19
Days to decision
199 days
Clearance type
Abbreviated
Product code
KWZ
Device class
2
Regulation number
888.3310
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, 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.

RecordFirmDate
Mpact Constrained Liner (K241461)Medacta International S.A.2025-07-31
PINNACLETM Constrained Acetabular Liners (K240639)Depuy Ireland UC2024-04-04
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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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10