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510(k) Data Aggregation
K Number
K002325Device Name
WUJIN #3 TIBIAL NAIL
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
2000-10-30
(90 days)
Product Code
JDS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992144Device Name
BIOPRO RIMMED ACETABULAR COMPOMENT
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1999-09-22
(90 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Osteoarthritis
2. Rheumatoid arthritis with severe hip pain and limited joint motion.
3. Avascular necrosis
4. Traumatic arthritis
5. Acetabular cavity deformities caused by congenital problems.
6. Revisional surgery after one or more total hip operations.
7. Fixation with bone cement and/or cancellous bone screws.
Device Description
The rimmed acetabular component is manufactured of Titanium 6 A1-4V Bli (ASTM F136). It is available in five sizes: 54mm, 58mm, 64mm, 70mm, and 76mm. The BioPro rimmed acetabular component accommodates BioPro's 28nun and 32mm Cox Comb inserts: 28x55 (10068), 28x58 (10069), 28x65 (10071), 28x69 (10074), 28x75 (11227), 32x55 (10077), 32x58 (10078), 32x65 (10081), 32x69 (10083), and 32x75 (10084).
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K Number
K964472Device Name
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1997-02-03
(88 days)
Product Code
KYI
Regulation Number
888.3770Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion.
Device Description
The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.
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K Number
K962769Device Name
HORIZON HIP SYSTEM
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1996-10-03
(79 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Both systems are indicated for treatment of osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.
Device Description
proprietary name: Horizon Hip System common name: prosthetic. Total Hip System classification name: prosthetic, Total Hip System
Femoral component: The Horizon Femoral Stem is manufactured from cobalt chrome and features a collar to distribute stress in a physiological manner. It is available with or without porous coating. The femoral component is available in five sizes: 12mm, 15mm, 16,5mm, and 18mm.
Acetabular Insert: The Horizon Acetabular Insert is manufactured of UHMWPE. It is designed to snap fit into the acetabular shell. The insert will accept 28mm heads. It is offered in sizes ranging from 46mm to 60mm.
Acetabular Shell (cup): The Horizon Acetabular Shell is manufactured of cobalt chrome. It features three spikes to prevent rotation. It also features a groove on its I.D. to accept the mating acetabular insert. The acetabular shell is porous coated to promote long term fixation. The acetabular shell is available in eight sizes: 46mm, 48mm, 52mm, 52mm, 56mm, 56mm, and 60mm.
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K Number
K955916Device Name
TOWNLEY TOTAL ELBOW SYSTEM
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1996-08-08
(223 days)
Product Code
JDC
Regulation Number
888.3150Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required.
Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.
Device Description
Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm.
Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large.
Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.
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K Number
K954768Device Name
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
Manufacturer
BIOLOGICALLY ORIENTED PROSTHESES
Date Cleared
1996-01-18
(93 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
BIOLOGICALLY ORIENTED PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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