Atlas FDA

TRIGEN Stable Lock Nut & Washer

FDA 510(k) clearance K243608 · decided 2025-06-12

Clearance details

K-number
K243608
Device name
TRIGEN Stable Lock Nut & Washer
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2024-11-22
Decision date
2025-06-12
Days to decision
202 days
Clearance type
Traditional
Product code
JDS
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
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061)Smith & Nephew, Inc.2024-09-20
TRIGEN INTERTAN 10S Nail System (K241804)Smith & Nephew, Inc.2024-08-22
NET BRAND Osteosynthesis Nailing System (K233150)Narang Medical , Ltd.2024-02-20
TRIGEN META-NAIL Nail System (K230761)Smith & Nephew, Inc.2023-06-14
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm (K201336)Synthes (USA) Products, LLC2020-09-03
Auxein Nailing System (K192003)Auxein Medical Private Limited2020-06-10
WIN Flexible Nail System (K193533)Biomet, Inc.2020-02-20
CONVENTUS PHS SYSTEM (K141737)Conventus Orthopaedics, Inc.2015-04-08
CHINA NAILS AND ACCESSORIES (K123948)Smith & Nephew, Inc.2013-03-14
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667)Synthes (Usa)2011-12-05
CONNEXX LOCKING TIBIA NAIL (K080706)I.T.S. Implantat-Technologie-Systeme GmbH2008-06-09
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS (K072095)Synthes (Usa)2007-09-27

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