Atlas FDA

JET-X HA COATED HALF PINS

FDA 510(k) clearance K023921 · decided 2003-02-05

Clearance details

K-number
K023921
Device name
JET-X HA COATED HALF PINS
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2002-11-25
Decision date
2003-02-05
Days to decision
72 days
Clearance type
Special
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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Recalls involving this device

RecordFirmDate
4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & recall (Z-1725-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & recall (Z-1726-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & recall (Z-1727-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & recall (Z-1728-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith & recall (Z-1729-2012)Smith & Nephew Inc2012-06-06
6 MM X 15 MM X 150 MM HA COATED HALF PIN SST, REF 71070828, QTY: (1), STERILE R, Smith & N recall (Z-1730-2012)Smith & Nephew Inc2012-06-06
6 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070800, QTY: (1), STERILE R, Smith & N recall (Z-1731-2012)Smith & Nephew Inc2012-06-06
6 MM X 25 MM X 150 MM HA COATED HALF PIN SST, REF 71070802, QTY: (1), STERILE R, Smith & N recall (Z-1732-2012)Smith & Nephew Inc2012-06-06
6 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070804, QTY: (1), STERILE R, Smith & N recall (Z-1733-2012)Smith & Nephew Inc2012-06-06
6 MM X 35 MM X 150 MM HA COATED HALF PIN SST, REF 71070806, QTY: (1), STERILE R, Smith & N recall (Z-1734-2012)Smith & Nephew Inc2012-06-06
6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith & N recall (Z-1736-2012)Smith & Nephew Inc2012-06-06
6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY: (1), recall (Z-1737-2012)Smith & Nephew Inc2012-06-06
6 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070810, QTY: (1), STERILE R, Smith & N recall (Z-1738-2012)Smith & Nephew Inc2012-06-06
6 MM X 55 MM X 150 MM HA COATED HALF PIN SST, REF 71070812, QTY: (1), STERILE R, Smith & N recall (Z-1739-2012)Smith & Nephew Inc2012-06-06
6 MM X 60 MM X 150 MM HA COATED HALF PIN SST, REF 71070814, QTY: (1), STERILE R, Smith & N recall (Z-1740-2012)Smith & Nephew Inc2012-06-06
6 MM X 65 MM X 150 MM HA COATED HALF PIN SST, REF 71070816, QTY: (1), STERILE R, Smith & N recall (Z-1741-2012)Smith & Nephew Inc2012-06-06
6 MM X 70 MM X 150 MM HA COATED HALF PIN SST, REF 71070818, QTY: (1), STERILE R, Smith & N recall (Z-1742-2012)Smith & Nephew Inc2012-06-06
6 MM X 20 MM X 200 MM HA COATED HALF PIN SST, REF 71070801, QTY: (1), STERILE R, Smith & N recall (Z-1743-2012)Smith & Nephew Inc2012-06-06
6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & N recall (Z-1744-2012)Smith & Nephew Inc2012-06-06
6 MM X 30 MM X 200 MM HA COATED HALF PIN SST, REF 71070805, QTY: (1), STERILE R, Smith & N recall (Z-1745-2012)Smith & Nephew Inc2012-06-06
6 MM X 35 MM X 200 MM HA COATED HALF PIN SST, REF 71070807, QTY: (1), STERILE R, Smith & N recall (Z-1746-2012)Smith & Nephew Inc2012-06-06
5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932948, recall (Z-1767-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932951, recall (Z-1768-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932952, recall (Z-1769-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932953, recall (Z-1770-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932961, recall (Z-1771-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932962, recall (Z-1772-2012)Smith & Nephew Inc2012-06-06

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