(67 days)
Not Found
No
The document describes a mechanical implant (femoral stem) and its physical properties and testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a prosthetic implant (femoral stem for hip replacement), which replaces a body part, rather than directly treating a disease or condition for therapeutic purposes in the way a therapeutic device typically would (e.g., pain relief, rehabilitation, monitoring, or drug delivery). While it leads to pain relief and improved function, its primary classification is as an implant/prosthetic.
No
This device is a prosthetic implant (hip stem) for use in total hip arthroplasty, which is a treatment rather than a diagnostic procedure. Its intended use is to reduce pain and improve hip function, not to diagnose a condition.
No
The device description clearly states the device is a monolithic stem manufactured from forged titanium alloy, indicating it is a physical implant, 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 to address musculoskeletal conditions. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The description details a physical implant made of titanium alloy, designed for surgical implantation. This is consistent with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, the PROFEMUR® TL Classic Stems are a medical device for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROFEMUR® TL Classic Stems are 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 dvsplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis:
-
- correction of functional deformity: and,
-
- revision procedures where other treatments or devices have failed.
The PROFEMUR® TL Classic Stems are single use components. intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI
Device Description
The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® TL Hip System. The PROFEMUR® TL Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® TL Classic Stems are available in 12 sizes (1-12) and are coated with titanium plasma spray conforming to ASTM F1580. Each size is available in two neck offset options, Standard (neutral) and Extended (varus). The distal stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PROFEMUR® TL Classic Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4, 6, and 8 and satisfied the acceptance criteria of each. Range of motion was evaluated in accordance with ISO 21535 and the subject device satisfied the acceptance criteria. The titanium plasma spray coating is applied according to WMT specification and is identical to that used in the predicate device (K060358). The titanium plasma spray coating was verified by testing present within a vendor Master File and summarized within this premarket notification.
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.
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).
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K123688 (pg 1/3)
PROFEMUR® TL Classic Stems Special 510(k) 510(k) Summary
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in bold, black letters. Underneath the word is a black graphic design. The letters "FER" are in the bottom right corner of the image.
808
510(k) Summary
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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® TL Classic Stems.
(a)(1) Submitted By:
Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (800) 238-7188
Date:
Contact Person:
(a)(2) Proprietary Name of Modified Device:
Common Name:
Classification Name and Reference:
Subject Product Code and Panel Code:
(a)(3) Predicate Devices:
November 20, 2012
Yuan Li, PhD Regulatory Affairs Specialist II
PROFEMUR® TL Classic Stems
Femoral Hip Stem
888.3353 LZO Hip joint metal/ceramic/polymer, cemented or non-porous, uncemented prosthesis Class II
888.3350 JDI Hip joint metal/polymer semiconstrained cemented prosthesis Class II
Orthopedics/87/JDI/LZO
PROFEMUR® TL Hip Stem, K060358
Headquarters Wright Medical Technology, Inc. 901.867.9971 phone www.wmt.com
Tab 07: Page 1 of 3
1
K123688 (pg 2/3)
PROFEMUR® TL Classic Stems Special 510(k) 510(k) Summary
Image /page/1/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic design element that appears to be two stylized, overlapping arrows or chevrons pointing in opposite directions. The overall impression is a logo or branding element, possibly for a company or organization named Wright.
(a)(4) Device Description
The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® TL Hip System. The PROFEMUR® TL Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® TL Classic Stems are available in 12 sizes (1-12) and are coated with titanium plasma spray conforming to ASTM F1580. Each size is available in two neck offset options, Standard (neutral) and Extended (varus). The distal stem geometry, neck length, and neck offset are designed to create options identical to those available with the predicate modular device.
(a)(5) Indications for Use
The PROFEMUR® TL Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patiests with the following conditions:
- l . 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® TL Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
(a)(6) Technological Characteristics of the Device
The indications for use of the PROFEMUR® TL Classic Stems are identical to those for the predicate device (K060358). The subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating (ASTM 1580) as the predicate device. The PROFEMUR® TL Classic Stems are designed to provide identical range of sizes, neck lengths, and neck offsets as those provided by the modular predicate with the exception of featuring a monolithic neck design and a slightly modified impaction slot.
(b)(1) Nonclinical Testing
The PROFEMUR® TL Classic Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4, 6, and 8 and satisfied the acceptance criteria of each. Range of motion was evaluated in accordance with ISO 21535 and the subject device satisfied the acceptance criteria. The titanium plasma spray coating is applied according to WMT specification and is identical to that used in the predicate device (K060358). The titanium plasma spray coating was verified by testing present within a vendor Master File and summarized within this premarket notification.
Tab 07: Page 2 of 3
2
PROFEMUR® TL Classic Stems Special 510(k) 510(k) Summary
Image /page/2/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are two stylized, overlapping shapes that resemble arrows or chevrons. The shapes are filled with black and have a slightly textured appearance.
(b)(2) Clinical Testing
Clinical data was not provided for the subject devices.
(b)(3) Conclusions
The indications for use and fundamental scientific technology of the PROFEMUR® TL Classic Stems are identical to those of the predicate device. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The safety and effectiveness of the PROFEMUR® TL Classic Stems is adequately supported by the substantial equivalence information. materials information, and nonclinical testing data provided within this premarket notification.
Headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com
Tab 07: Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff.
Public Health Service
Letter dated: February 8, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated % Yuan Li Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K123688
Trade/Device Name: PROFEMUR® TL Classic Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, JDI Dated: November 26, 2012 Received: December 3, 2012
Dear Yuan Li:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Yuan Li
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PROFEMUR® TL Classic Stems Special 510(k) Indications for Use Statement
Image /page/5/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a thick, black line that appears to be a stylized underline or logo element. The text and the line are both in black, contrasting with the white background.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K123688 (pg 1/1)
Device Name: PROFEMUR® TL Classic Stems
Indications for Use:
The PROFEMUR® TL Classic Stems are 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 dvsplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis:
-
- correction of functional deformity: and,
-
- revision procedures where other treatments or devices have failed.
The PROFEMUR® TL Classic Stems are single use components. intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens
Division of Orthopedic Devices
Headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com
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