(85 days)
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:
-
- noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- 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.
This implant is intended for cementless use.
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.
This document is a 510(k) summary for a premarket notification for a hip implant, specifically the Orthopedic Source Press-fit Hip. This is a medical device approval for a physical product and not a software device, therefore, the requested information about acceptance criteria and studies (test set, ground truth, expert involvement, etc.) is not applicable in the context of AI/software performance.
The document describes the device, its intended use, and compares its technological characteristics to a predicate device (Taperloc Hip). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified.
The "testing" mentioned in this document is in the context of mechanical engineering analysis for the hip implant's strength and durability, not for a software algorithm's performance.
Therefore, I cannot populate the table or provide details on the study types (MRMC, standalone), sample sizes for test/training sets, or methods for establishing ground truth, as these concepts are relevant to software/AI device evaluation and not to the mechanical device described in this 510(k) summary.
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| Orthopedic Source Press-fit Hip | |
|---|---|
| 510(k) Summary | |
| April 14, 2006 |
| Submitter | Orthopedic Source, Inc. |
|---|---|
| 20501 Ventura Blvd. | |
| Suite 225 | |
| Woodland Hills, CA 91364 |
JUL 1 8 2006
| Contact person | J.D. Webb |
|---|---|
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 | |
| Trade Name | Orthopedic Source Press-fit Hip |
| Common name | Press-fit hip |
| Classification name | Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented |
| Per 21 CFR Sec. 888.3358 | |
| Product Code | LPH |
| Equivalent Device | Taperloc Hip (Biomet, K921301) |
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.
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.
Summary of Technological Characteristics Compared to Predicate Device
The results of an engineering analysis shows that the strength of the Orthopedic Source 7.5mm Offset Hip is slightly greater than the Taperloc 7.5mm Hip.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 18 2006
Orthopedic Source, Inc. c/o J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K061124
Trade/Device Name: Orthopedic Source Press-fit Hip Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: June 5, 2006 Received: June 29, 2006
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 – Mr. J.D. Webb
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bruchur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO61124 Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
-
- noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- 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.
This implant is intended for cementless use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Beechn
Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061124
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.