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Found 39 results
510(k) Data Aggregation
K Number
K243761Device Name
A.L.P.S. Small Fragment Plating System
Manufacturer
Biomet Orthopedics
Date Cleared
2025-02-19
(75 days)
Product Code
HRS, HTN, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Biomet Orthopedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
Device Description
The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.
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K Number
K223631Device Name
Comprehensive Segmental Revision System(SRS)
Manufacturer
Biomet Orthopedics
Date Cleared
2023-07-12
(219 days)
Product Code
KWT, JDC, KWS, MBF, PHX
Regulation Number
888.3650Why did this record match?
Applicant Name (Manufacturer) :
Biomet Orthopedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Comprehensive® Segmental Revision System is intended for use in cases of:
- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Revision where other devices or treatments have failed.
- 3. Correction of functional deformity.
- 4. Oncology applications including bone loss due to tumor resection.
When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.
When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.
Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.
The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.
The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.
Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.
Device Description
The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.
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K Number
K200196Device Name
Taperloc® Complete Hip Stems
Manufacturer
Biomet Orthopedics
Date Cleared
2020-12-08
(316 days)
Product Code
LZO, JDI, KWL, KWY, KWZ, LPH, MAY, MEH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
Biomet Orthopedics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Taperloc® Complete Hip Stems are intended for hip joint arthroplasty.
1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union. Femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed
Porous coated components are intended for uncemented biological fixation.
Device Description
Taperloc® Complete Hip Stems are an implant device, a porous coated femoral stem intended for uncemented biological fixation. The Taperloc® Complete is a series of hip stems with a bi-planar wedge design, titanium substrate, and proximally circumferential titanium porous plasma sprayed design.
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K Number
K131393Device Name
MAK OSS FEMORAL KNEE COMPONENTS
Manufacturer
BIOMET ORTHOPEDICS CORP.
Date Cleared
2013-10-24
(162 days)
Product Code
KRO
Regulation Number
888.3510Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus or post-traumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).
* Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
Device Description
The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.
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K Number
K112905Device Name
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
Manufacturer
BIOMET ORTHOPEDICS LLC.
Date Cleared
2012-05-24
(234 days)
Product Code
MBF, JDC, KWS, KWT
Regulation Number
888.3670Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Compress® Segmental Humeral Replacement System is indicated for:
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.
The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.
The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Device Description
The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.
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K Number
K080528Device Name
E-POLY TIBIAL BEARINGS
Manufacturer
BIOMET ORTHOPEDICS, INC.
Date Cleared
2008-06-17
(112 days)
Product Code
JWH, MBH, MBV, OIY
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
For cemented and un-cemented use.
Device Description
The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)
The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.
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K Number
K072879Device Name
INNERVUE DIAGNOSTIC SCOPE SYSTEM
Manufacturer
BIOMET ORTHOPEDICS, INC.
Date Cleared
2008-01-14
(97 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
Device Description
The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).
Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.
Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.
Scope: A rigid fiber optic scope designed for one-time use.
Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.
Procedural Kits: Supplementary items to assist in the surgical procedure.
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K Number
K070955Device Name
ACID ETCHED LAG SCREWS
Manufacturer
BIOMET ORTHOPEDICS, INC.
Date Cleared
2007-10-12
(190 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K033355Device Name
LACTOSCREW SCREW ANCHOR
Manufacturer
BIOMET ORTHOPEDICS, INC.
Date Cleared
2004-06-30
(254 days)
Product Code
HWC, MAI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.
Device Description
This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.
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K Number
K032286Device Name
CALCIGEN PSI BONE GRAFT SUBSTITUTE
Manufacturer
BIOMET ORTHOPEDICS, INC.
Date Cleared
2003-11-20
(119 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BIOMET ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.
Device Description
Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.
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