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510(k) Data Aggregation
K Number
K020145Device Name
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
2002-04-15
(89 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
3. patients with failed previous surgery where pain, deformity, or dysfunction persists;
4. revision of previously failed hip arthroplasty; and
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Device Description
The Renewal™ Acetabular Cup System consists of metal acetabular shells and UHMWPE acetabular liners.
The Renewal™ Acetabular Shell will be available in a hemispherical titanium alloy shell with and without a 2 mm peripheral rim flare. The shells will be coated with commercially pure titanium porous beads.
Design features of the Renewal™ Acetabular shell are summarized below:
- Total hemispherical design .
- Hemispherical design with a 2 mm peripheral flare .
- Coated with CPTi porous beads ●
- . No-Hole, 3-hole, 5-Hole, and 9-Hole options
- Threaded apical hole plug
The Renewal™ Acetabular Liners will be available with 0°, 10°, 15°, 20° overhangs with/without a 6+mm lateralized shift. The liner's internal geometry will be intended to be used with existing femoral heads manufactured from cobalt chrome or ceramic. The Renewal™ liner's external geometry will be designed to accept the Renewal™ Acetabular Shells.
Design features of the Renewal™ Acetabular Liner are summarized below:
- 360° liner overhang positioning options .
- Features an easy-to-assemble snap lock system to lock the liner into the shell .
- . The lip of the 10° and 20° liners will be full hemispheres
- The lip of the 15° liner will be machined to 180° .
- The liners will be offered with 0°, 10°, 15°, and 20° overhangs .
- The 0° and 10° liners will also be offered with a 6+mm lateralized shift ●
- Internal diameter will have a 2mm chamfer to minimize impingement. .
The thinnest part of any UHMWPE articulating insert will be greater than 4mm if attached to a metal backing.
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K Number
K983881Device Name
COBRA EXTERNAL FIXATOR
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
1998-12-04
(32 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.
Device Description
The device a two-piece hinged external fixator. Set-screws are used to secure orthopedic pins or K-wires to the fixator and establish the fixation angle.
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K Number
K962646Device Name
PRIME MODULAR ENDO HEAD
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
1996-09-23
(77 days)
Product Code
KWL
Regulation Number
888.3360Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.
Device Description
The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.
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K Number
K960014Device Name
PRACTIFIX EXTERNAL FIXATION SYSTEM
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
1996-03-18
(76 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.
Device Description
The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration
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K Number
K955620Device Name
PRIME CEMENTED CALCAR FEMORAL STEMS
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
1996-02-20
(71 days)
Product Code
JDI
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955751Device Name
PRIME FEMORAL CEMENT PLUG
Manufacturer
ORTHOPAEDIC INNOVATIONS, INC.
Date Cleared
1996-01-26
(37 days)
Product Code
LZN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPAEDIC INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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