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510(k) Data Aggregation

    K Number
    K033313
    Device Name
    QUATRO M FEMORAL COMPONENT
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    2004-07-28

    (287 days)

    Product Code
    LWJ, LPH, LZO
    Regulation Number
    888.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use. It is intended to be used for: - 1 . Noninflammatory degenerative joint disease including osteoarthritis - ನ Rheumatoid arthritis - . Pri Avascular necrosis - Correction of functional deformity 4. - ર . Revision procedures where other treatments or devices have failed - Treatment of non-unions, femoral neck and trochanteric fractures of the proximal Q. femur with head involvement that are unmanageable using other techniques
    Device Description
    The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AL-4V (ASTM 1472) stem with tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and medial – laterally with a grit blasted distal surfaces. The proximal stem will be porous coated with commercially pure titanium plasma spray on all proximal surfaces excluding the articular interface trunion. The femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunion. The distal portion of the stem will be grit blasted. Sterilization will be 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization.
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    K Number
    K012800
    Device Name
    SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    2002-05-03

    (255 days)

    Product Code
    HRY
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symmetric Unicompanimental Knee System is for Cemented Use Only and is indicated for restroing efther compartment of a knee that has been damaged by rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.
    Device Description
    The Symmetric Unicompartmental Knee System is intended for the resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components and a polyethylene tibial insert. The FEMORAL COMPONENT is symmetrically designed eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central peg, which aids in stabilization. A central strut is provided for rotational stability and added strength. The femoral component will be available in five sizes (1-5) and will be porous coated with Commercial Pure Titanium (CPTi). The TIBIAL COMPONENT is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6Al-4V). The tibial tray features a central fin and four pegs on the underside aiding in rotational stabilization. A screw hole is in the center of the tibial tray for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 5 sizes (1 - 5) and is porous coated with Commercial Pure Titanium (CPT)). The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semi-constrained and is captured in the tibial tray by the mating capture features. The insert is available in 5 thicknesses (6, 8, 10, 12, and 14mm) and 5 sizes (1 - 5).
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    K Number
    K003618
    Device Name
    WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    2001-05-23

    (182 days)

    Product Code
    NDD
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993903
    Device Name
    WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    2000-02-14

    (90 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    a) General orthopedic uses. b) Trochanteric reattachment. c) Fixation of long bone fractures-elbow, shoulder, ankle, patella. d) Trauma fixation of shoulder, ankle and patella . e) General spinal uses. f) Spinal wiring.
    Device Description
    This implant consists of a 0.058" diameter cable, 23" in length, 20" length cable and 3" length lead and a cylindrical crimp with a transverse "through hole". The crimp, cable and lead cable are supplied as a single assembled unit. All three are preassembled in the manufacturing process. The cable is manufactured according to the material specifications for ASTM F136-96 in a 7 x 7 x 0.00064 wire construct. The crimp is also manufactured from ASTM F136-96. A cable passer may be used to pass the free end of the cable around the bone. The free end is then passed through the transverse hole of the crimp in such manner as to have the free end emerge from the center of the crimp. A cable tensioner may be used to achieve a desired cable tension a which time the surgeon uses a crimper/cutter to crimp near the middle of the "through hole" and cuts the free end from the crimp.
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    K Number
    K991678
    Device Name
    WHITESIDE BIOMECHANICS SPINAL SYSTEM
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1999-08-12

    (87 days)

    Product Code
    KWQ, KWP, MNH
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is intended for use anterolateral/anterior, non-pedicle posterior and posterior pedicle. 1.) The device system consisting of pedicle screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: a.) Anterolateral screw fixation to the non-cervical spine, b.) Anterior screw fixation to the cervical spine. The anterolateral/anterior system is intended for use in the following indications: a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. b.) Spondylolisthesis c.) Trauma d.) Spinal Stenosis e.) Scoliosis f.) Kyphosis g.) Tumor h.) Pseudoarthrosis i.) Previous failed fusion 2.) The device system consiting of hooks, screws, washers, spacer, when utilized as a non-pedicle posterior system is intended for use in the following: a.) Hook and sacral/iliac screw fixation to the non-cervical spine. The non-pedicle posterior system is intended for use in the following indications: a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. b.) Spondylolisthesis c.) Trauma d.) Spinal Stenosis e.) Scoliosis f.) Kyphosis g.) Tumor h.) Pseudoarthrosis i.) Previous failed fusion 3.) The device system of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients: a.) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint: b.) Who are receiving fusions using autogenous bone graft only: c.) Who are having the device fixed or attached to the lumbar and sacral spine: and d.) Who are having the device removed after the development of a solid fusion mass. The levels of pedicle screws fixation are limited to L3-S1.
    Device Description
    A spinal system consisting of screws, hooks, washers, spacer and plates/screws. The pedicle screws are available in four diameters from 5mm to 8mm, and vary in length from 30mm to 55mm. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The anterior washers offer use with 5mm, 6mm, and 7mm screws. The Conical spacers are available in three heights from 7mm to 12mm, increasing in 2.5 increments. The lumbo-sacral rod/plate and screw incorporates lumbo-sacral rod/plates in three lengths from 80mm to 120mm, and bone screws with a 7mm diameter and lengths of 30mm to 45mm, increasing in 5mm increments. There are five laminar hooks and one pedicle hook with the range. The distal tips of the pedicle screws are fluted to a point beyond the first thread, thus creating a self-tapping screw configuration. The spinal rods have a diameter of 4.75mm and vary in length from 50mm to 500mm. The locking mechanism between the rod and screw, as well as the rod and hook, features a three point clamping configuration in order to significantly reduce the risk of rod positioning and migration. The devices are used to treat a number of spinal conditions. The devices are manufactured from Titanium Alloy ASTM F1472-93 or Stainless Steel ASTM F138. Only components manufactured from the same material may be used in combination.
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    K Number
    K981238
    Device Name
    BIPOLAR FEMORAL HEAD
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1998-08-21

    (140 days)

    Product Code
    KWY
    Regulation Number
    888.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for : - femoral noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - rheumatoid arthritis, - correction of functional deformity, - revision procedures where other treatments or devices have failed, and - treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    Device Description
    A bipolar head which is preassembled. Outer head is made from Cobalt Chrome alloy ASTM F75 and sizes range from 38mm to 62mm in 1mm increments. An UHMW polyethylene insert will be pressed into the inner surface of the outer head during the manufacturing process. This polyethylene insert will articulate with an inner femoral head. The inner head diameter will be 22mm for outer head diameters from 38mm to 55mm and 26mm for outer diameters from 56mm to 62mm. The inner head will be pressed into the poly insert in the operating room using a bipolar head assembly device.
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    K Number
    K973261
    Device Name
    WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1997-11-24

    (87 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for : - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - rheumatoid arthritis, - correction of functional deformity, - revision procedures where other treatments or devices have failed, and - treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    Device Description
    The Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head is composed of magnesia partially stabilized zirconia (MG-PSZ). The head is generally spherical with a Whiteside Biomechanics, Inc. 12/14 bore machined from distal to proximal. Around the base of the bore a flat will be machined and will be laser-engraved for labeling purposes.
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    K Number
    K964616
    Device Name
    QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1997-08-07

    (287 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for : - noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - rheumatoid arthritis, - correction of functional deformity, - revision procedures where other treatments or devices have failed, and - treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
    Device Description
    The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4 V (ASTM 1472) stem with a tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and will have step-cut sides medial-laterally. The proximal stem will be porous coated with commercially pure titanium plasma spray on all surfaces excluding the articular interface trunnion.
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    K Number
    K971721
    Device Name
    WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1997-07-30

    (82 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. rheumatoid arthritis 3. correction of functional deformity 4. revision procedures where other treatments or devices have failed 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 6. treatment of osteomyelitis 7. endoprosthesis femoral osteotomy 8. use with a polyethylene cup with or without metal backed shell.
    Device Description
    The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.
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    K Number
    K971718
    Device Name
    MICRO-SEAL ACETABULAR SYSTEM
    Manufacturer
    WHITESIDE BIOMECHANICS, INC.
    Date Cleared
    1997-07-23

    (75 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHITESIDE BIOMECHANICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used for: - noninflammatory degenerative joint disease including 1. osteoarthritis and avascular necrosis - rheumatoid arthritis, 2. - correction of functional deformity, 3. - revision procedures where other treatments or devices have 4. failed, - 5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    Device Description
    This implantable device consists of a generally hemispherical shape titanium shell with six screw holes for optional additional fixation with bone screws. A UHMWPE modular liner is pressed or tapped into the shell. Push out resistance of the polyethylene is attained by the interlocking geometry of the shell. Rotational fixation is obtained by tabs located on the liner that mate with notches on the shell. Toggle fixation is achieved with the nub on the backside The inner surface of the of the liner fitting into the driver hole through the shell. polyethylene articulates with the spherical portion of the femoral component.
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