(28 days)
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No
The document describes a mechanical hip stem implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for reduction or relief of pain and/or improved hip function, which are therapeutic benefits aimed at improving a patient's health.
No
The device is a hip stem used in total hip arthroplasty to reduce pain and improve hip function; it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a hip stem manufactured from titanium alloy, which is a physical implant, not software.
Based on the provided information, the PROFEMUR® RENAISSANCE™ Hip Stem is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty to treat conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and materials of a hip stem, which is a physical implant. IVD devices typically involve reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, the PROFEMUR® RENAISSANCE™ Hip Stem is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PROFEMUR® RENAISSANCE™ 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
Product codes (comma separated list FDA assigned to the subject device)
LWJ, JDI, LZO, JDL, KWA, LPH
Device Description
- Manufactured from titanium alloy (Ti6A14V) .
- . Offered in two medial flare options
- . 1mm increments from size 10-18
- Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating
- Cylindrical, splined, and slotted distal stem with glassbead surface ◆
- Threaded hole with slot impaction mechanism .
- . Polished distal tip and collar
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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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§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented 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. This generic type of device is limited to those prostheses intended for use with 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 a cemented 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 a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
AUG 2 2 2005
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three stylized, wing-like shapes arranged horizontally. The wings are filled with a textured pattern, giving them a shaded appearance. In the bottom right corner, there is a small "TM" symbol, indicating a trademark.
Koslags
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 CRF 807, this information serves as a Mour Dories: 110 01 1775etiveness for the use of the PROFEMUR® RENAISSANCE™ Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | July 22, 2005 |
| Contact Person: | Theresa Leister |
| Regulatory Affairs Specialist | |
| Proprietary Name: | PROFEMUR® RENAISSANCE™ Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II |
| 21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular component prosthesis -- Class III | |
| 21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III | |
| 21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented - Class II | |
| 21 CFR 888.3353 Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented- Class II |
Device Product Code and Panel Code:
Orthopedics/87/ LWJ, JDI, LZO, JDL, KWA
1
International subsidiaries
ton, TN 38002 90
1
DEVICE INFORMATION
A. INTENDED USE
The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mre 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.
B. DEVICE DESCRIPTION
The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- . Offered in two medial flare options
- . 1mm increments from size 10-18
- Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface � with HA coating
- Cylindrical, splined, and slotted distal stem with glassbead surface ◆
- Threaded hole with slot impaction mechanism .
- . Polished distal tip and collar
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® RENAISSANCE™ Hip Stem 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® RENAISSANCE™ Hip Stem are 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 is a black and white circular seal. The seal contains the logo of the U.S. Department of Health and Human Services. The logo features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K051995
Trade/Device Name: PROFEMUR® RENAISSANCE™ Hip Stem Regulation Number: 21 CFR 888.3320, 21CFR 888.3330, 21CFR 888.3350, 21 CFR 888.3353, 21CFR 888.3358 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: III Product Code: JDL, KWA, JDI, LZO, LPH Dated: July 22, 2005 Received: July 25, 2005
Dear Ms. Leister:
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.
3
Page-2- Ms. Theresa Leister
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.
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 yours.
Mark N. Melkerson Acting 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):
Device Name: PROFEMUR® RENAISSANCE™ IHip Stem
Indications For Use:
Hip Stem is indicated for use in total hip The PROFEMUR® RENAISSANCE™ 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; 2.
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page I of 1
510(k) Number_6051995