Atlas FDA

TRIGEN HINDFOOT FUSION NAIL

FDA 510(k) clearance K043052 · decided 2004-11-24

Clearance details

K-number
K043052
Device name
TRIGEN HINDFOOT FUSION NAIL
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2004-11-05
Decision date
2004-11-24
Days to decision
19 days
Clearance type
Special
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Smith & Nephew

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.

RecordFirmDate
Pangea Femur Reconstruction System (K261481)Stryker GmbH2026-06-29
Precice™ Max System and Precice™ Ankle Salvage System (K261651)NuVasive Specialized Orthopedics2026-06-18
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080)Suzhou and Science & Technology Development Corp.2026-06-18
Fule Metallic Lockable Intramedullary Nail Systems (K253155)Beijing Fule Science & Technology Development Co., Ltd.2026-06-17
HERA Interlocking Intramedullary Nailing System (K253046)ZheJiang Decans Medical Devices Co., Ltd.2026-06-16
FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146)Orthofix Srl2026-05-19
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991)Orthofix Srl2026-05-08
AUTOBAHN™ Nailing System (K261043)Globus Medical, Inc.2026-04-24
Arthrex Humeral Nails (K252016)Arthrex, Inc.2026-03-20
Fusion FibFix Nail (K252961)Fusion Orthopedics USA, LLC2026-03-18
Affixus Retrograde Femoral Nailing System (K253566)Zimmer, Inc.2026-03-12
Reselute Tibial Nail (K253517)Reselute, Inc.2026-03-10

Recalls involving this device

RecordFirmDate
TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for recall (Z-2082-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated f recall (Z-2083-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated f recall (Z-2084-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for recall (Z-2085-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for recall (Z-2086-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated recall (Z-2087-2008)Smith & Nephew Inc2008-09-16
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated recall (Z-2088-2008)Smith & Nephew Inc2008-09-16

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