(30 days)
Not Found
No
The summary describes a mechanical device (distal centralizers) made of PMMA for use in hip arthroplasty. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical and material testing.
No
The device is described as a "PMMA Distal Centralizer" used in total hip arthroplasty to guide the implant and center the hip stem. It bears no body weight and its primary function is mechanical guidance during surgery, not directly providing therapeutic treatment or pain relief. The pain relief and improved hip function mentioned are outcomes of the total hip arthroplasty, not directly attributable to the centralizer itself.
No
The device description clearly states its purpose is to guide and center a hip stem implant during total hip arthroplasty, not to diagnose medical conditions.
No
The device description clearly states it is a molded PMMA centralizer, which is a physical component used in surgery, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the PMMA Distal Centralizers are physical components used within the body during a surgical procedure (total hip arthroplasty). They are placed in the femoral canal to guide a hip stem implant.
- Intended Use: The intended use is for surgical implantation to improve hip function and reduce pain in patients with specific hip conditions. This is a therapeutic and structural function, not a diagnostic one performed on a sample outside the body.
The device is a surgical implant component, not a diagnostic test.
N/A
Intended Use / Indications for Use
Wright Distal Centralizers are intended for use in cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
- 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
Wright Distal Centralizers are indicated for cemented hip arthroplasty.
- revision procedures where other treatments or devices have failed
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDL, LZO, JDI
Device Description
The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives. The following tests on the predicate apply to the subject material: Kligman sensitization, intracutaneous injection, reverse mutagen assay, chromosomal aberration assay, rodent micronucleus assay, and a 4-week bone implantation assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal
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)
Nonclinical Testing: The PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer have been tested by mechanical testing (compressive strength), residual monomer analysis (HPLC), molecular weight analysis (GPC), differential scanning calorimetry, FTIR, NMR, GC-MS, and cytotoxicity.
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
§ 888.3330 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.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS NOV 1 0 2011
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® Gladiator HA Hip Stems.
| Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd, Arlington TN, 38002
(800) 238-7188 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | September 30, 2011 |
| Contact Person: | Matt Paul
Project Regulatory Affairs Specialist |
| Proprietary Name: | PROFEMUR® X™ Wingless Distal Centralizer
PERFECTA® Distal Centralizer |
| Common Name: | Centralizer |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/metal semi-
constrained, with an uncemented acetabular
component prosthesis Class |
| Subject Product Code and Panel Code: | Orthopedics/87/KWA, JDL, LZO, JDI |
| Predicate Devices Name and Number: | PROFEMUR® X™ (PROFEMUR XTR)
NEXUS™ Femoral Hip Stem |
| | 510(k): K052915, K911052 |
| Predicate Classification and Number: | Orthopedics/87/ KWA, 888.3330 |
Device Information
A. Device Description
The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives. The following tests on the predicate apply to the subject material: Kligman sensitization, intracutaneous injection, reverse mutagen assay, chromosomal aberration assay, rodent micronucleus assay, and a 4-week bone implantation assay.
The subject material for the PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer was evaluated via mechanical testing (compressive strength), residual monomer analysis (HPLC), molecular weight analysis (GPC), and cytotoxicity. A review of these results indicates that
1
the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.
B. Intended Use
Wright Distal Centralizers are intended for use in cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
- 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
Wright Distal Centralizers are indicated for cemented hip arthroplasty.
C. Technological Characteristics of the Device
The PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer have the same technological characteristics as the predicate devices. The PMMA Distal Centralizers are placed on the distal end of the hip stem implant during its final insertion into the bone, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within the femoral canal, and thereby allow a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The material used for the Distal Centralizers identically conforms to ASTM F451 as does the material used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.
D. Nonclinical Testing
The PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer have been tested by mechanical testing (compressive strength), residual monomer analysis (HPLC), molecular weight analysis (GPC), differential scanning calorimetry, FTIR, NMR, GC-MS, and cytotoxicity
E. Clinical Testing
Clinical data was not provided for the centralizers.
F. Conclusions
The indications for use of the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are identical to the previously cleared predicate devices. The design features of the devices are unchanged. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 0 2011
Wright Medical Technology, Inc. % Matt Paul 5677 Airline Rd Arlington, TN 38002
Re: K113019
Trade/Device Name: Profemur X™ Wingless Distal Centralizers Perfecta Distal Centralizers
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, JDL, LZO, JDI
Dated: September 30, 2011
Received: October 11, 2011
Dear Mr. Paul:
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. 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
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Page - 2 - Mr. Matt Paul
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 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/CDRH/CDRHOffices/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 N. Me Director Division of Surgical, Orthopedic and Restorative 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. Underneath the word is a design that looks like three wings. The wings are angled and have a dark, textured appearance.
Kf13019
Indications for Use
Device Name: PROFEMUR® X™ Wingless Distal Centralizer PERFECTA® Distal Centralizer
Indications For Use:
The PMMA Distal Centralizers are intended 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:
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
The PMMA Distal Centralizers are single use components, intended for use as part of a cemented 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)
Michell Wills for MXM
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113019