(90 days)
Not Found
Not Found
No
The device description focuses solely on the mechanical components and materials of the hip prosthesis. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is a hip implant indicated for conditions like osteoarthritis, avascular necrosis, and fractures, which are therapeutic interventions aimed at relieving pain and improving function.
No
The device is a modular prosthesis for total hip arthroplasty, intended for the treatment of various degenerative joint diseases and fractures, not for diagnosing them.
No
The device description clearly details a physical, modular hip prosthesis made of multiple hardware components (distal stem, proximal body, extension adapter, modular neck) with specific dimensions and materials (plasma spray coating). There is no mention of any software component.
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 treat various hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip prosthesis (stems, bodies, adapters, necks). This is consistent with a medical device implanted in the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The PRO-FEMUR Hip System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ, MAY
Device Description
The PRO-FEMUR Hip with plasma spray coating is a modular prosthesis comprising of four principal parts:
- Distal Stem
- Proximal Body
- Extension Adapter
- Modular Neck
The PRO-FEMUR distal stem with plasma spray coating will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of 1mm from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are cylindrical with plasma spray coating and a bullet shaped distal tip.
The PRO-FEMUR Proximal Body with plasma spray coating will be available in seven different sizes: Extra Small, Small, 4x Standard, and Large. The four standard components have the same length but became progressively wider.
The distal stem is secured to the proximal body by a morse taper and secondly by a fixation screw.
To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.
The proximal body has a specific oblong housing for the insertion of the twelve modular necks.
The design features of PRO-FEMUR Hip System with plasma spray coating are substantially equivalent to the design features of competitive devices previously cleared for market.
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)
Not Found
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.
Not Found
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
OCT - 3 2001
lord
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 Summary of Safety and Effectiveness for the use of the PRO-FEMUR Hip System.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc.
July 3, 2001
Ehab M. Esmail Manager, Regulatory Affairs
PRO-FEMUR
TOTAL HIP SYSTEM
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENT - Class II
PROSTHESIS. HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED- Class II
Device Product Code and Panel Code:
Orthopedics/87/ LWJ and LZO
DEVICE INFORMATION
A. INTENDED USE
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;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Image /page/0/Picture/29 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the name is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font with a line above it.
Image /page/0/Picture/30 description: The image shows a black and white graphic of a globe. The globe is partially obscured by a dark, irregular shape, possibly representing a landmass or cloud cover. The globe is surrounded by a circular border, which is also partially obscured. The image has a grainy texture, suggesting it may be a low-resolution scan or a photocopy.
510(K) SUMMARY
1
The PRO-FEMUR Hip System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
B. DEVICE DESCRIPTION
The PRO-FEMUR Hip with plasma spray coating is a modular prosthesis comprising of four principal parts:
- Distal Stem 해
- Proximal Body 미
- 에 Extension Adapter
- 용 Modular Neck
5107RT SUMMARY " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
The PRO-FEMUR distal stem with plasma spray coating will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of Irum from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are cylindrical with plasma spray coating and a bullet shaped distal tip.
The PRO-FEMUR Proximal Body with plasma spray coating will be available in seven different sizes: Extra Small, Small, 4x Standard, and Large. The four standard components have the same length but became progressively wider.
The distal stem is secured to the proximal body by a morse taper and secondly by a fixation screw.
To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.
The proximal body has a specific oblong housing for the insertion of the twelve modular necks.
The design features of PRO-FEMUR Hip System with plasma spray coating are substantially equivalent to the design features of competitive devices previously cleared for market.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of PRO-FEMUR Hip System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PRO-FEMUR Hip System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2001
Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K012091
Trade/Device Name: PRO-FEMUR Hip System 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, LWJ, MAY Dated: July 3, 2001 Received: July 5, 2001
Dear Mr. Esmail:
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.
3
Page 2 -- Mr. Ehab M. Esmail
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
for Mark N Mulkern
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
4
Image /page/4/Picture/0 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the company name.
PRO-FEMUR HIP SYSTEM
INDICATIONS STATEMENT
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;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
(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 Devices 510(k) Number
Prescription Use
(Per21 CFR 801.109)
Mark n Milkuson
Over-The Counter Use (Optional Format 1-2-96)
- Restorative
5100k) Number
Image /page/4/Picture/17 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
INDICATIONS STATEMENT
Image /page/4/Picture/19 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and has a vintage look.