Atlas FDA

SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]

FDA 510(k) clearance K994143 · decided 2000-02-18

Clearance details

K-number
K994143
Device name
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
1999-12-08
Decision date
2000-02-18
Days to decision
72 days
Clearance type
Traditional
Product code
JDW
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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MAVERICK External Fixation System (K213874)Smith & Nephew, Inc.2022-02-11
Steinmann Pins and Kirschner Wires (K211508)Stryker GmbH2021-10-05
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Recalls involving this device

RecordFirmDate
JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, recall (Z-1747-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & recall (Z-1748-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & recall (Z-1749-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & recall (Z-1750-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & recall (Z-1751-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & recall (Z-1752-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & recall (Z-1753-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & recall (Z-1754-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & recall (Z-1755-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & recall (Z-1756-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & recall (Z-1757-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & recall (Z-1758-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, QTY: (1), STERILE R, Smith & recall (Z-1759-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & recall (Z-1760-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & recall (Z-1761-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & recall (Z-1762-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, QTY: (1), STERILE R, Smith & recall (Z-1763-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & recall (Z-1765-2012)Smith & Nephew Inc2012-06-06
Smith & Nephew Orthopaedics PIP (proximal Interphalangeal) FIXATION HINGE KIT, REF 101638, recall (Z-2027-2009)Smith & Nephew Inc2009-09-15

PMA approvals by this applicant

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Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
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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