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Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Reverse Applications The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the Implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Comprehensive Convertible Glenoid Baseplate components are Intended for cementless applications with the addition of screw fixation. Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Convertible Glenoid Baseplate is round, truncated on the anterior and posterior sides. The baseplate features a medial boss through which a Central Screw is placed to hold the component in place. The back surface of the component is porous coated. There are two peripheral screw holes through the baseplate. Screws are available in both locking and non-locking styles. When used with a polyethylene liner, the construct is designed to articulate with a metallic humeral head attached to a humeral stem in a traditional, anatomic total shoulder configuration. Should revision to a reverse shoulder construct be desirable, the polyethylene liner can be removed without removal of the baseplate and replaced with a glenosphere component.

Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty. Indications For Use: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM). (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner. This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

Biomet Sports Medicine™ Anchors and ZipLoop™ Constructs are intended for use In soft Intended DSC. District oper of it the shoulder, foot / ankle, elbow, knee, hand / wrist, and hip. The Biomet suture anchor devices have similar indications for use with one Indication for Use statement for nonresorbable anchor devices and another for resorbable anchor devices. ZipLoop™ Constructs may be (esoraged separately (one Indication for Use Statement covers a ZipLoop™ Construct packaged separately) or preloaded on suture anchors In place of sutures (an Indication for Use statement for non-resorbable anchor device with ZipLoop™ Construct and another for a resorbable anchor device with a ZipLoop™ Construct). Specific indications for use are as follows: Anchor devices without ZipLoop Constructs: Device Name: Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK Anchors Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK and Hitch™ PEEK Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific Indications are as follows: Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle: Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs Elbow: Blceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee: ACL/PCL (only for ALLthread™ Titanlum and ALLthread™ PEEK anchors), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Reallgnment / Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx, Ulnar/Radial Collateral Ligament Reconstruction Acconstraction) Tenash Titanium and ALLthread™ PEEK), Volar Plate Reconstruction Hip: Labral Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hltch™ L-15 Suture Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows: Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee: ACL/PCL (only for ALLthread™ L-15), Illiotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb) (not Including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not including Hitch™ L-15), Ulnar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15}, Volar Plate Reconstruction (not Including Hitch™ L-15) Hip: Labral ZipLoop™ Constructs packaged separately: Device Name: Full, Bowtie and Half Zip-Loop™ Constructs Full, Bowtle and Half ZipLoop™ Constructs are indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, knee, and hip. When a ZipLoop™ Construct is packaged separately, the specific Indications for use are as follows: Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs / Reconstruction, Midfoot/Forefoot Reconstruction / Repairs Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee: ACL/PCL (only for 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblal Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Ulnar/Radial Collateral Ligament Reconstruction (only for 2-0 or larger UHMWPE Full and Bowtie ZipLoop™ Construct), Volar Plate Reconstruction Hip: Labral When a ZipLoop™ Construct Is packaged with a Blomet Sports Medicine™ internal fixation device, please refer to the package insert included with the surgeon's choice of internal fixation device for specific indications. Anchor devices packaged with ZlpLoop™ Constructs: Device Name: Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs Ti-Screw, ALLthread™ Titanlum, ALLthread™ PEEK and Hitch™ PEEK Anchors with ZipLoop Constructs are Indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows: Shoulder: Acromio-Clavlcular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Blceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle: Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs Elbow: Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee: ACL/PCL (only for ALLthread™ Titanium and ALLthread™ PEEK anchors in conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Illiotiblai Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment / Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Ulnar/Radial Collateral Ligament Reconstruction (only for Tl-Screw, ALLthread™ Titanium and ALLthread™ PEEK In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct); Volar Plate Reconstruction Hip: Labral Device Name: ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15 Suture Anchors with ZipLoop Constructs are indicated for soft tissue reattachment procedures in the shoulder, foot and ankle, elbow, knee, hand and wrist, and hip. Specific indications as follows: Shoulder: Acromio-Clavicular Separation, Anterior Shoulder Instability Repair, Bankart Lesion Repairs, Biceps Tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle: Achilles Tendon Repair / Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot / Forefoot Reconstruction / Repairs Elbow: Bloeps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral / Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee: ACL/PCL (only for ALLthread™ L-15 in conjunction with 2-0 or larger UHMWPE Full or Bowtle ZipLoop™ Construct), Illiotiblal Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist: Collateral Ligament Repair (Gamekeeper's Thumb) (not including Hitch™ L-15), Scapholunate Ligament Reconstruction, Tendon Transfers In Phalanx (not Including Hitch™ L-15), Uinar/Radial Collateral Ligament Reconstruction (only for ALLthread™ L-15 and LactoScrew® L-15 In conjunction with 2-0 or larger UHMWPE Full or Bowtie ZipLoop™ Construct), Volar Plate Reconstruction (not including Hitch™ L-15) Hip: Labral

The Blomet Sports Medicine™ suture anchor devices (Ti-Screw, ALLthread™ Titanium, ALLthread™ PEEK, Hitch™ PEEK, ALLthread™ L-15, LactoScrew® L-15, MicroMax™ and Hitch™ L-15) Suture Anchors are internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation due to injury or degenerative disease. The devices are available preloaded with suture and / or a ZipLoop™ Construct. The Biomet Sports Medicine™ ZipLoop™ Constructs provide a flexible, adjustable means of soft tissue The blomer in a manner that does not require the surgeon to the a knot in sutures. The ZipLoop™ Constructs are available in three configurations and two strand materials.

The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated. 1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants. 2. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty. 3. Sternotomy indications include the "re-wiring" of sternums following osteotomy. 4. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.

1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis. 3) Correction of functional deformity. 3) Correction of functional neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5) Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications

Biomet Manufacturing Corp. is modifying the manufacturing process of ultrahigh molecular weight polyethylene (UHMWPE) used in the fabrication of polyethylene acetabular mgh molecular naglio partiles. The modified manufacturing process results in a higher cross-linked polyethylene. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.

The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. These devices are single-use implants intended for implantation with bone cement.

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM). The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is indicated for cemented application only.

The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement

1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2) Correction of varus, valgus, or posttraumatic deformity. 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

The Vanguard™ Anatomic Patella Groove (APG) / Vanguard™ V Groove product line is a two piece system intended for use with additional tibial products to replace the patellofemorotibial joint space. The system is composed of one type of femoral and two types of patellae. The system can be used with any commercially available Biomet® Tibial Tray, Vanguard™ CR, CR-L, or AS bearing, or augment. The femoral component is cruciate retaining (CR) in both left and right configurations. The femoral implants are available in both Interlok® and porous finish. The sizes of femoral implants range from: 55 - 80mm. Two different all-polyethylene patellae designs will function with the new femoral components a round, modified dome and a medially offset patella. Both designs have 3-pegs, concentric grooves, and cement pockets for cement fixation.