Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2013 | Cayenne Medical Inc. AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction. Terminated |
HWC | K083612 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| Jun 12, 2013 | OrthoPediatrics Corp 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole
Product Usage:
The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies i Terminated |
HWC | K110959 |
| May 24, 2013 | Orthopedic Alliance LLC Co-Cr cancellous bone screw,15mm
Co-Cr cancellous bone screw,20mm
Co-Cr cancellous bone screw,25mm
Co-Cr cancellous bone screw,30mm
Co-Cr cancellous bone screw,35mm
Co-Cr cancellous bone screw,40mm
V Terminated |
HWC | None listed |
| Mar 28, 2013 | Synthes USA HQ, Inc. Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set)
The Synthes Dens instrument Set has been designed to facilitate internal fixatio Terminated |
HWC | None listed |
| Jan 30, 2013 | Biomet, Inc. TUNNELOC ROUND HEAD INTERFERENCE SCREW
8MMX25MM
Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requ Terminated |
HWC | K934469 |
| Jan 30, 2013 | Extremity Medical LLC Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010.
This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the sc Terminated |
HWC | K101700 K121347 |
| Nov 19, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
Torx 6.5mm
Cancellous Bone Screw
Ref 2030-6535-1
The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. Th Terminated |
HWC | K894124 |
| Nov 19, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics
Torx 6.5mm
Cancellous Bone Screw
Ref 2030-6525-1
The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. Th Terminated |
HWC | K894124 |
| Nov 18, 2012 | Extremity Medical LLC IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079.
The Extremity Medical Screw and Washer System is intended for reduction and internal Terminated |
HWC | K101700 |
| Nov 6, 2012 | Zimmer, Inc. NCB screw 4.0 self-tapping Terminated |
HWC | K061211 |
| Nov 6, 2012 | Zimmer, Inc. NCB cancellous screw Terminated |
HWC | K061211 |
| Oct 25, 2012 | Encore Medical, Lp 6.5mm Cancellous Bone Screw
Intended to be used for the fixation of the acetabular shell or fracture repair. Terminated |
HWC | K931665 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5 w/out Needles with violet and blue Orthocord
Product Number: 222988
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indi Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5 w/Needles with violet and blue Orthocord
Product Number: 222987
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicate Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/out Needles with violet and blue Orthocord
Product Number: 222986
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indi Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/Needles with violet and blue Orthocord
Product Number: 222985
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicate Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5 w/out Needles with Orthocord
Product Number: 222971
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5 w/Needles with Orthocord
Product Number: 222970
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/out Needles with Orthocord
Product Number: 222969
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0 w/Needles with Orthocord
Product Number: 222968
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. Screw, fixation, boneProduct Number: 222967
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Ethibond without needles
Product Number: 222966
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Panacryl without needles
Product Number: 222965
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Ethibond without needles
Product Number: 222964
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Panacryl and needles
Product Number: 222963
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 6.5mm with Ethibond and needles
Product Number: 222962
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Panacryl and needles
Product Number: 222961
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 25, 2012 | DePuy Mitek, Inc., a Johnson & Johnson Co. SpiraLok 5.0mm with Ethibond and needles
Product Number: 222960
SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in Terminated |
HWC | K041069 K060271 |
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | K082574 |
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | K082574 |
| Aug 6, 2012 | Encore Medical, Lp djo surgical Screw 6.5 mm, Sz 25mm, low profile.
Product is intended for the fixation of the acetabular shell or fracture repair Terminated |
HWC | K931665 |
| Mar 21, 2012 | Biomet, Inc. REF 905948, 2.MM Hitch Suture (Lactosorb Anchor L15 2#1,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905581, 6.8 mm Lactoscrew 2#2 MB wI NDL, (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring De Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Device Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tissue An Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft T Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medicine Soft Tis Terminated |
HWC | K080088 |
| Mar 21, 2012 | Biomet, Inc. REF 905463, 2.9 mm Micromax Anchor Long Shaft, Size 2 Blue/White Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN
Product Usage: The Biomet Sports Medi Terminated |
HWC | K080088 |
| Mar 19, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm
Catalog Number: 72201772.
The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anter Terminated |
HWC | K080358 |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor
Intended for rotator cuff repair Terminated |
HWC | K042584 |
| Oct 14, 2011 | ArthroCare Corporation ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007;
Product is manufactured and distributed by Ar Terminated |
HWC | K042584 |
| Jul 22, 2011 | Biomet Microfixation, Inc. "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA* Terminated |
HWC | K953385 |
| Jun 17, 2011 | Wright Medical Technology Inc ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002
The ENDO Terminated |
HWC | K051309 |
| Jun 17, 2011 | Wright Medical Technology Inc ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355,
IMPLANT MATERIAL: Wright Medical Technology, Inc , 5677 Airline Road, Arlington, TN Terminated |
HWC | K051309 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | K071498 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 12 mm x 18 mm, REF 982366, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | K071498 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 11 mm x 17 mm, REF 982365, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | K071498 |
| Mar 9, 2011 | Biomet, Inc. STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN.
Used to reduce excessive rearfoot pronation by blocking forward and downward displ Terminated |
HWC | K071498 |
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