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510(k) Data Aggregation
K Number
K061124Device Name
ORTHOPEDIC SOURCE PRESS-FIT HIP
Manufacturer
ORTHOPEDIC SOURCE INC.
Date Cleared
2006-07-18
(85 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC SOURCE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthopedic Source Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of: 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-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.
Indications for Use:
- 1) noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This implant is intended for cementless use.
Device Description
The Orthopedic Source stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is a collarless flat wedge-shaped implant that provides excellent durability and stability in a design that is relatively simple and predictable to implant. The use of a collarless designity the Orthopedic Source hip tends to allow for self seating of the implant and achievement of optimal rotational stability, immediately after implantation. The incorporation of standard and lateralized offset options provides the surgeon the ability to reconstruct a stable joint with proper leg length in virtually all patient anatomies. The Orthopedic Source Stem has a 135° rack shaft angle and a standard 12/14 Morse type taper is incorporated in to the geometry to receive modular heads. The proximal body is circumferentially coated with commercially pure titanium plasma spray. Femoral heads are manufactured from wrought CoCrMo alloy conforming to ASTM F799 and are available in 22m, 28mm and 32mm diameters and multiple neck lengths.
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K Number
K022711Device Name
MODIFICATION TO AVALON CUP SYSTEM
Manufacturer
ORTHOPEDIC SOURCE INC.
Date Cleared
2002-08-26
(12 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC SOURCE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:
1. Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
2. Inflammatory degenerative joint disease including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head Involvement that are unmanageable using other techniques.
Device Description
The Avalon cup is manufactured from Titanium 6AL 4V Eli (ASTM F136). The Avalon Cup is porous coated with commercial pure (CP) titanium sintered beads (ASTM F67) to promote fixation. The Avalon Cup is a low profile cup available in three versions: [No-hole], [Three hole], and a [Multi-hole]. The holes are to allow for added fixation with bone screws. The Avalon Cup's outer geometry consists of a 14° flared rim and 8 external cutouts, which are machined into the peripheral exterior of the cup.
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K Number
K011887Device Name
AVALON CUP SYSTEM
Manufacturer
ORTHOPEDIC SOURCE INC.
Date Cleared
2001-12-27
(192 days)
Product Code
JDI, LWJ, LZO
Regulation Number
888.3350Why did this record match?
Applicant Name (Manufacturer) :
ORTHOPEDIC SOURCE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:
- 1) Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
- 2) Inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) Correction of functional deformity;
- 4) Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Device Description
Not Found
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