(567 days)
Not Found
No
The 510(k) summary describes a mechanical implant (femoral stem) and its coating. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The device description focuses on the physical design and materials.
Yes.
This device is intended to relieve pain and improve hip function in patients with various degenerative joint diseases and fractures, which are therapeutic effects.
No
This device is a femoral stem used in total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint, not to diagnose a condition. Its purpose is therapeutic, not diagnostic.
No
The device description clearly identifies the device as a "Femoral Stem," which is a physical implant used in hip replacement surgery. It is a hardware device, 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, which is a procedure performed in vivo (within the body) to replace a damaged hip joint. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a femoral stem, a component of a hip implant. This is a physical device implanted into the bone, not a reagent, instrument, or system used to analyze biological samples.
The information provided aligns with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The PERFECTA® Femoral Stem with calcium sulfate coating 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 1 . necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; 3.
- revision procedures where other treatments or devices have failed; and, 4.
- treatment of fractures that are unmanageable using other techniques. 5.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The design features and functions of the first of the currently available The design features and functions of the Peter Petures of the currently available coating will be identical to the 100 110 - 11 F000022, with the exception of the coating will be identical to the design features and railorions PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.
ourerally could be available in a range of sizes (9-22.5 mm) and will feature the All Tembral Dedical Technology (SLT) 12/14 taper.
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.
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
§ 888.3358 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.
0
NOV 2 2 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the room and in conformance with 21 CRF 807, this information serves as a Medical Dovices For of Serviveness for the use of the PERFECTA® Femoral Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | May 2, 2003 |
| Contact Person: | Ehab M. Esmail |
| Senior Manager, Regulatory Affairs | |
| Proprietary Name: | PERFECTA® Femoral Stem |
| Common Name: | TOTAL HIP SYSTEM |
| Classification Name and Reference: | 21CFR 888.3358 Hip joint metal/polymer/metal, |
| semi-constrained porous coated uncemented | |
| prosthesis | |
| 21CFR 888.3350 Hip joint metal/polymer, semi- | |
| constrained, cemented prosthesis - Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/ LPH, and JDI |
DEVICE INFORMATION
A. INTENDED USE
The PERFECTA® Femoral Stem with calcium sulfate coating 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 1 . necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; 3.
- revision procedures where other treatments or devices have failed; and, 4.
- treatment of fractures that are unmanageable using other techniques. 5.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology ceramic or metal femoral heads, acetabular liners and shells, as a part of an uncemented total hip arthroplasty.
1
B. DEVICE DESCRIPTION
DL VICE DEBOTED TIME .
The design features and functions of the first of the currently available The design features and functions of the Peter Petures of the currently available
coating will be identical to the 100 110 - 11 F000022, with the exception of the coating will be identical to the design features and railorions
PERFECTA® Femoral Stem (510(k): K991123 and K004032), with the exception of the calcium sulfate coating.
ourerally could be available in a range of sizes (9-22.5 mm) and will feature the All Tembral Dedical Technology (SLT) 12/14 taper.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of the PERFECTA" The intended lise, malerial, type of microos, are substantially equivalent to the Femoral Stem with calciall suffato coating and control of the market (510(k): K991123 and K004032).
100 1052).
The safety and effectiveness of the PERFECTA® Femoral Stem with californation, marcrials The satety and effectiveness of the substial equivalence information materials
coating are adequatedy supported by the subscription Promarket Notification coating are adequately supported by the sabetainler of any and
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K031402
Rosi402
Trade/Device Name: Calcium Sulfate Coated Perfecta® Femoral Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: August 20, 2004 Received: August 24, 2004
Dear Mr. Esmail:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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 for use surved in the excess, 1976, the enactment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, de noos that hat t over wat 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 rou mayy arous 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) This letter wif anow you've ough finding of substantial equivalence of your device to a legally prematics notification. The Processification 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 If you desire specific acries in 1 240) 276-0120. Also, please note the regulation entitled, Connact the Office or Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational 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,
Cilia Wither
Celia M. Witten, PhD, MD Director Division of General, Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in all caps. Below the word is a graphic of three diagonal lines that are stacked on top of each other. Below the graphic is the letters "TM".
PERFECTA® Femoral Stem INDICATIONS STATEMENT
510(k) Number (if known):
Device Name: PERFECTA® Femoral Stem
Indications For Use:
The PERFECTA® Femoral Stem with calcium suffate coating 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 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis, 2.
-
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, 4.
-
- treatment of fractures that are unmanageable using other techniques.
The PERFECTA® Femoral Stem with calcium sulfate coating is for single use only, and is intended for use in conjunction with existing Wright Medical Technology cerainic or metal femoral heads, acetabular liners and shells, as a part of an uncemented 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| headquarters
| Wright Medical Technology, Inc. | 5677 Airline Road Arlington, TN 38002 |
|---|---|
| 510(k) Number | K031402 |
| Phone | 901.867.9971 |
| Website | www.wmt.com |
| International subsidiaries | |
|---|---|
| 011.32.2.378.3905 Belgium | 905.826.1600 Canada |
| 011.39.0250.678.227 Italy | 011.81.3.9538.0474 Japan |
| 011.33.1.45.13.24.40 France | |
| 011.44.1483.721.404 UK | |
| 011.49.4161.745130 Germany |