Atlas FDA

Smith & Nephew Intramedullary Nail Systems

FDA 510(k) clearance K210980 · decided 2022-11-14

Clearance details

K-number
K210980
Device name
Smith & Nephew Intramedullary Nail Systems
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2021-04-01
Decision date
2022-11-14
Days to decision
592 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Cordova, 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
Pangea Femur Reconstruction System (K261481)Stryker GmbH2026-06-29
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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 PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 recall (Z-2456-2026)Smith & Nephew, Inc.2026-06-16
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 recall (Z-1806-2025)Smith & Nephew, Inc.2025-05-19
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur recall (Z-2443-2023)Smith & Nephew, Inc.2023-08-22
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur recall (Z-2444-2023)Smith & Nephew, Inc.2023-08-22

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