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Found 13 results
510(k) Data Aggregation
K Number
K990392Device Name
DEPUY ACE SPIDER PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1999-03-23
(42 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- · Fixation of Metaphyseal Fractures of the Distal Tibia
- · Proximal Metaphyseal Tibial Fractures
- · Calcaneus Body Fractures
- · Proximal Humeral Head/Shaft Fractures
- · Distal Femur Fracture Comminuted Shaft Fractures
- · Fixation of soft tissue, such as tendon and ligaments, to bone
Device Description
The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.
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K Number
K990120Device Name
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1999-02-01
(19 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Pilon fractures distal tibial intra-articular fractures
- High medial malleolar fractures
- Low boot top type rotational distal extra-articular shaft fractures
Device Description
The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
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K Number
K984458Device Name
DEPUY ACE SPIDER PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-12-31
(16 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- · Fixation of Metaphyseal Fractures of the Distal Tibia
- · Proximal Metaphyseal Tibial Fractures
- · Calcaneus Body Fractures
- · Proximal Humeral Head/Shaft Fractures
- · Distal Femur Fracture -- Comminuted Shaft Fractures
Device Description
The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.
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K Number
K983853Device Name
DEPUY ACE TIMAX META PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-12-22
(53 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Distal intra-articular tibia fractures
- Proximal tibia fractures
- Proximal and distal humerus fractures
Device Description
The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.
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K Number
K983265Device Name
DEPUY ACE COMPOSITE LOCKING NUT
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-10-26
(39 days)
Product Code
HTN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required
Device Description
The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.
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K Number
K982347Device Name
DEPUY ACE TIMAX PILON PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-08-31
(56 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Pilon fractures - distal tibial intra-articular fractures
- High medial malleolar fractures
- Low Boot top type rotational distal extra-articular shaft fractures
Device Description
The DePuy ACE TiMAX™ Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with four screw holes and two k-wire guide holes for the distal metaphyseal region, and finally, an arm which wraps anteriorly to address the anterior crush fracture and facilitate articular surface reconstruction. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The shaft portion is thicker for strength. The plate is supplied pre-formed to a contour, which closely matches the distal tibia anatomy. The general contour includes a medial bend from the distal metaphyseal region combined with an internal rotation. The most distal profile includes the anterior arm with a large bend from the medial to the anterior surface with the bend apex located adjacent to the anterior strut. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate will be offered in a right and left model with various lengths of the shaft region. The DePuy ACE TiMAX™ Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
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K Number
K981775Device Name
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-07-29
(70 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:
- Intra-articular fractures of the calcaneus .
- Extra-articular fractures of the calcaneus .
Device Description
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-4V ELI (per ASTM standard F136).
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K Number
K974245Device Name
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1998-05-22
(191 days)
Product Code
LXT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
- Cervical fractures
- Ligamentous injury of the cervical spine
- Fusion or other surgery of the cervical spine
Device Description
The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.
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K Number
K972183Device Name
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
Manufacturer
ACE MEDICAL CO.
Date Cleared
1997-08-26
(77 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.
Device Description
The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.
The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).
The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.
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K Number
K970503Device Name
DEPUY ACE TROCHANTERIC SIDE PLATE
Manufacturer
DEPUY ACE MEDICAL CO.
Date Cleared
1997-04-30
(79 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEPUY ACE MEDICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.
Device Description
The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6A1-4V alloy.
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