(87 days)
The Global Press-fit 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.
The Global Press-fit stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is available is sizes ranging from 9mm to 17mm. The body tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a tri-planar wedge geometry that is conducive to axial and rotational stability. The distal stem is conical in shape with sharp splines to enhance rotational stability. Stems larger than 11mm have a coronal slot in the distal third to aid in the reduction of thigh pain. A Morse type taper is used to attach modular femoral heads. The stem is available with neutral, and right and left anteverted necks. No calcar collar is present on this stem. The proximal lateral shoulder of the stem has a threaded hole for insertion and extraction tools. The proximal body of the stem has a circumferential porous coating of sintered CP titanium beads (ASTM F67). The femoral heads utilized with the Global Press-fit Hip are machined from wrought CoCrMo alloy (ASTM F799). They are available in 22mm, 28mm diameters. The 22mm heads have two neck lengths, while the 28mm and 32mm heads have five neck lengths.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Global Press-fit Hip as requested.
Based on the provided text, the "study" conducted for the Global Press-fit Hip is primarily an engineering analysis comparing its strength to predicate devices, rather than a clinical trial with human subjects or a diagnostic algorithm performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Equivalent strength to predicate devices (Foundation Hip 8mm Porous) when tested per ISO 7206-4, assuming no critical geometrical differences in failure areas. | "The strength of the Global 9mm Hip is virtually the same as the Foundation 8mm Porous Hip." |
| Material Composition | Conforms to specified ASTM standards. | Stem: Ti-6Al-4V alloy conforming to ASTM F136. Porous coating: Sintered CP titanium beads (ASTM F67). Femoral Heads: Wrought CoCrMo alloy (ASTM F799). |
| Design/Geometry | Similar to predicate devices (Foundation Hip). | "The stem geometry of the Global Press-fit stem is similar to the Foundation Hip." |
| Porous Coating Process | Same as the predicate device (Foundation Hip). | "undergo the exact same porous coating process." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set. The evaluation was primarily an engineering analysis, likely involving a limited number of physical prototypes or computational models for the mechanical strength comparison. No human subject data (prospective or retrospective) is mentioned.
- Data Provenance: Not applicable in the context of an engineering comparison of device characteristics. There's no country of origin for "data" as it pertains to patient information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Experts: The document does not mention the use of experts to establish "ground truth" for a test set of data in a diagnostic or clinical performance context. The expertise would lie with the engineers who conducted the material and mechanical comparisons.
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" requiring adjudication in the sense of expert review for ground truth. The comparison method was an engineering analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (hip implant), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on established engineering standards, material specifications (ASTM), and comparative mechanical performance against legally marketed predicate devices. It relies on:
- Published ASTM standards: For material composition.
- ISO 7206-4 standard: For mechanical strength testing of femoral components.
- Known characteristics of predicate devices: For comparison of geometry, materials, and manufacturing processes.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" and therefore no ground truth was established for it.
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Date July 31, 2003
OCT 3 0 2003
Submitter
Global Medical Co. Box 515 4848 Highland Dr. Salt Lake city, UT 84117
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Press-fit hip
Classification name
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (per 21 CFR section 888.3358)
Equivalent Device
The Global Press-fit Hip is equivalent in design, materials and indications as the Foundation Hip (K991226, Encore Medical) and Progressive Hip (Biomet).
Device Description
The Global Press-fit stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is available is sizes ranging from 9mm to 17mm. The body tapers proximal to distal in the lateral and frontal planes, and lateral to medial in the sagittal plane resulting in a tri-planar wedge geometry that is conducive to axial and rotational stability. The distal stem is conical in shape with sharp splines to enhance rotational stability. Stems larger than 11mm have a coronal slot in the distal third to aid in the reduction of thigh pain.
A Morse type taper is used to attach modular femoral heads. The stem is available with neutral, and right and left anteverted necks. No calcar collar is present on this stem. The proximal lateral shoulder of the stem has a threaded hole for insertion and extraction tools.
The proximal body of the stem has a circumferential porous coating of sintered CP titanium beads (ASTM F67).
The femoral heads utilized with the Global Press-fit Hip are machined from wrought CoCrMo alloy (ASTM F799). They are available in 22mm, 28mm diameters. The 22mm heads have two neck lengths, while the 28mm and 32mm heads have five neck lengths.
Intended Use
The Global Press-fit Hip Stem is intenting 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 stem geometry of the Global Press-fit stem is similar to the Foundation Hip. They both are fabricated from Ti-6A1-4V alloy and undergo the exact same porous coating process. Therefore, as long as there are no geometrical features in the area where the stems would fail while being tested per ISO 7206-4 an engineering analysis is a valid method to compare the strength of these two press-fit stems.
The results of this analysis show that the strength of the Global 9mm Hip is virtually the same as the Foundation 8mm Porous Hip.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head in profile, composed of three curved lines. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Global Medical Co. C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032385 Trade/Device Name: Global Press-fit Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: July 31, 2003 Received: August 4, 2003
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 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.
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Page 2 - Mr. J.D. Webb
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 (301) 594- . 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/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number (if known):
Device Name: Global Press-fit Stem
Indications for Use:
Global Press-fit Stem Indications for Use
Kos 2385
The Global Press-fit 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.
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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional format 1-2-96)
Mark A. Milliman
in Sign-Off Division of Coneral, Restorative and Neurological Devices 510(k) Number _
Page iii
§ 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.