Atlas FDA

CONQUEST FN

FDA 510(k) clearance K193029 · decided 2020-02-28

Clearance details

K-number
K193029
Device name
CONQUEST FN
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2019-10-30
Decision date
2020-02-28
Days to decision
121 days
Clearance type
Traditional
Product code
JDO
Device class
2
Regulation number
888.3030
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
OsteoCentric Integrated Hip Fastener System (K230764)OsteoCentric Technologies2023-04-18
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126)Smith & Nephew, Inc.2022-09-29
OsteoCentric Integrated Hip Fastener System (K210247)Osteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30
THP Hip Fracture Plating System (K173826)Biomet, Inc.2018-02-07
CONQUEST FN (K172785)Smith & Nephew2017-12-22
CONQUEST FN (K152686)Smith & Nephew2016-03-17
TSP HIP FRACTURE PLATING SYSTEM (K140018)Biomet, Inc.2014-04-04
HIPLOC COMPRESSION HIP SCREW (K080685)Biomet Manufacturing, Inc.2008-08-15
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434)Smith & Nephew, Inc.2008-04-10
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (K983814)Efratgo, Ltd. HI Tech Bio-Surgical1999-01-14
SYNTHES (USA) DHS HELIX SYSTEM (K981757)Synthes (Usa)1998-07-17
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259)Synthes (Usa)1997-01-09

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