(29 days)
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No
The document describes a hip stem implant and its intended use and design features. There is no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is indicated for reduction or relief of pain and/or improved hip function, which are therapeutic outcomes.
No
The device is a hip stem (implant) used in total hip arthroplasty, not equipment for diagnosing medical conditions.
No
The device description clearly states it is a hip stem manufactured from titanium alloy, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty, addressing conditions like osteoarthritis and rheumatoid arthritis. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details the physical characteristics of a hip stem (material, coating, size, etc.), which is a medical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PROFEMUR® LX 5/8 Coated Hip Stem does not fit this description.
N/A
Intended Use / Indications for Use
The PROFEMUR® LX 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LZO, MBL
Device Description
The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V)
- Proximal 5/8 of stem plasma sprayed .
- . Offered in Sizes 10-18
- Polished distal tip and collar .
- Threaded hole with slot impaction mechanism .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The indications for use of the PROFEMUR® LX 5/8 Coated Hip Stem are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K081090 (pg 1/2)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 15 2008
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® LX 5/8 Coated Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 28, 2008 |
| Contact Person: | Ryan Ross |
| Regulatory Affairs Specialist | |
| Proprietary Name: | PROFEMUR® LX 5/8 Coated Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/ metal semi- |
| constrained, with an uncemented acetabular | |
| component prosthesis - Class III |
Device Product Code and Panel Code:
Orthopedics/87/ KWA. LZO. MBL
DEVICE INFORMATION
A. Intended Use
The PROFEMUR® LX 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.
1
KOBIO90 (pg 212)
B. Device Description
The design features of the PROFEMUR® LX 5/8 Coated Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) ●
- Proximal 5/8 of stem plasma sprayed .
- . Offered in Sizes 10-18
- Polished distal tip and collar .
- Threaded hole with slot impaction mechanism .
C. Substantial Equivalence Information
The indications for use of the PROFEMUR® LX 5/8 Coated Hip Stem are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® LX 5/8 Coated Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, which is a staff entwined with snakes, representing medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Ryan Ross Regulatory Affairs Specialist 5677 Airline Road Arlington, TN 38002
MAY 15 2008
K081090 Re: Trade/Device Name: PROFEMUR® LX 5/8 Coated Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LZO, MBL Dated: April 14, 2008 Received: April 18, 2008
Dear Mr. Ross:
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. Ryan Ross
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081090 (pcs) / 1 )
Device Name: PROFEMUR® LX 5/8 Coated Hip Stem
Indications For Use:
The PROFEMUR® LX 5/8 Coated Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milke Oil for men
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K081090
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