Atlas FDA

PLC SCREW

FDA 510(k) clearance K051310 · decided 2005-07-26

Clearance details

K-number
K051310
Device name
PLC SCREW
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2005-05-19
Decision date
2005-07-26
Days to decision
68 days
Clearance type
Traditional
Product code
HWC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Andover, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligame recall (Z-0593-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligame recall (Z-0594-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N recall (Z-0595-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligame recall (Z-0596-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligame recall (Z-0597-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N recall (Z-0598-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N 7211115, Ligame recall (Z-0599-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N 7211116, Ligame recall (Z-0600-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N 7211117, Ligame recall (Z-0601-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligame recall (Z-0602-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N 7211119, Ligame recall (Z-0603-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligame recall (Z-0604-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligame recall (Z-0605-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligam recall (Z-0606-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N 7211123, Ligam recall (Z-0607-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligam recall (Z-0608-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligam recall (Z-0609-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N 7211126, Ligam recall (Z-0610-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligam recall (Z-0611-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N 72201069, Ligam recall (Z-0612-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N 72201070, Ligam recall (Z-0613-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N 72201071, Liga recall (Z-0614-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N 72201072, Liga recall (Z-0615-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm, P/N recall (Z-0616-2008)Smith & Nephew, Inc. Endoscopy Division2008-03-19

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