(324 days)
Not Found
No
The 510(k) summary describes a standard mechanical hip replacement system and its components. There is no mention of AI, ML, image processing, or any software-driven features that would suggest the use of such technologies. The performance studies are focused on mechanical testing.
Yes
A total hip arthroplasty system is used to replace a damaged hip joint articulation, which directly addresses disease conditions such as osteoarthritis and avascular necrosis of the femoral head, with the intent to reduce pain and increase patient mobility, thus providing therapeutic benefit.
No
This device is a total hip arthroplasty system intended for replacing damaged hip joints. It is a therapy device, not a diagnostic one. Its purpose is to repair, not to diagnose conditions.
No
The device description clearly outlines physical components such as femoral stems, acetabular cups, femoral heads, and screws, which are hardware implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a system for Total Hip Arthroplasty, which is a surgical procedure to replace a damaged hip joint with artificial components. These components are implanted directly into the patient's body.
- Intended Use: The intended use is to "provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation." This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Excera Orthopedics FitMore™ Total Hip Arthroplasty System is intended to be used for primary total hip replacement in skeletally mature individuals. The System's modular design provides a large selection of component sizes.
The System includes three stem designs; a double tapered Femoral Stem (uncemented) with the proximal metaphyseal portion CpTi plasma spray coated, a double-tapered Femoral Stem (un-cemented) with the same essential proximal taper inclusive of a distal stem portion to be inserted in the diaphysis, and the Optimum Femoral Stem (Cemented), a collarless, highly polished double-taper cemented Femoral Stem with design features known to provide reliable performance.
The System's CoCrMo Femoral Heads interlock with the Femoral Stems via a standard taper attachment, providing accurate placement and secure fixation.
There are three different uncemented Acetabular Cup designs allowing for adjunct fixation; two with specifically designed screw hole patterns, and one with protruding "spurs" designed to fixate to the previously prepared acetabular surface. The Ti6Al4V Acetabular Cups are CpTi plasma spray coated on the trabecular surface. The Ti6A14V Acetabular Screws are available in 6 lengths from 15 to 40mm in 5mm increments.
The conventional non-cross-linked UHMWE Acetabular Liners are available in various diameters corresponding to the Femoral Heads and Acetabular Cups, and in 10 degree elevated and standard, non-elevated rim configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Prescription Use
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)
Testing in accordance with ASTM/ISO standards was used to evaluate mechanical performance.
- ASTM F2068: Proximal Fatigue (Pass)
- ISO 7206-4:2010: Distal Fatigue (Pass)
- ISO 21535:2007: Range of Motion (Pass)
- ASTM F1875: Taper Fretting (Pass)
- ASTM F2009: Femoral Head Distraction (Pass)
- ASTM F1820: Liner Push out, Lever out & Torque out (Pass)
- ASTM F543: Screw Insertion Torque & Max Torque (Pass)
In addition, coating characterization testing was performed on the subject device.
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.
K061461, K030265, K071723, K071784, K001534, K033273, K922247
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2015
Excera Orthopedics, Incorporated % Mr. Tim M. Lohnes Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484
Re: K140547
Trade/Device Name: Excera FitRite™ Total Hip Arthroplasty System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI Dated: December 19, 2014 Received: December 22, 2014
Dear Mr. Lohnes:
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 comply with all the Act's requirements, including, but not limited to: registration and listing
1
Page 2 - Mr. Tim M. Lohnes
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140547
Device Name
Excera FitRite™ Total Hip Arthroplasty System
Indications for Use (Describe)
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip
replacement.
- Certain cases of ankylosis.
The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
FitRite™ Total Hip Arthroplasty System
510(k) Summary
Submitter's Information [21 CFR 807.92(a)(1)]
Tim M. Lohnes, Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Phone: (203)922-0105 Fax: (203)922-0130
Orchid Design has received authorization to submit this 510(k) on behalf of the sponsor; Excera Orthopedics, Inc., 1188 Centre St. Newton, MA 02459. Establishment Registration Number: 3009752723
Date Prepared [21 CFR 807.92(a)(1)]
February 21/April 9/April 25/December 19, 2014/January 22, 2015
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Excera FitRite™ Total Hip Arthroplasty System |
|---|---|
| Common Name: | Total Hip Prosthesis |
| Panel Code: | Orthopedics/87 |
DDH, Standard Stems, Cups, liners, heads, screws (Un-cemented)
Classification Name and Reference: 21 CFR §888.3358-Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented.
Class/Product Code: 2/LPH
Optimum Cemented Stem (CoCr) (Cemented)
Classification Name and Reference: 21 CFR §888.3350-Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Class/Product Code: 2/JDI
Predicate Device(s) [21 CFR 807.92(a)(3)]
The components of the Excera Total Hip Arthroplasty System are substantially equivalent to the following previously cleared devices;
-
The DDH & Standard Stems; Zimmer Mayo® Conservative Hip Prosthesis (K061461)
-
The Cemented stems; Zimmer CPT 12/14 Femoral Stem (K030265) and Zimmer Fitmore (K071723)
4
Excera Orthopedics, Inc.
FitRite™ Total Hip Arthroplasty System
-
The Acetabular Cups; DePuy Pinnacle w/ Gripton (K071784)
-
The Acetabular Liners Screws; DePuy Pinnacle Acetabular System (K001534)
-
The femoral heads; DePuy Ultima™ Unipolar Femoral Head, (K033273)
-
The cement restrictors; Kinamed REALITY, (K922247)
Description of the Device [21 CFR 807.92(a)(4)]
The Excera Orthopedics FitMore™ Total Hip Arthroplasty System is intended to be used for primary total hip replacement in skeletally mature individuals. The System's modular design provides a large selection of component sizes.
The System includes three stem designs; a double tapered Femoral Stem (uncemented) with the proximal metaphyseal portion CpTi plasma spray coated, a double-tapered Femoral Stem (un-cemented) with the same essential proximal taper inclusive of a distal stem portion to be inserted in the diaphysis, and the Optimum Femoral Stem (Cemented), a collarless, highly polished double-taper cemented Femoral Stem with design features known to provide reliable performance.
The System's CoCrMo Femoral Heads interlock with the Femoral Stems via a standard taper attachment, providing accurate placement and secure fixation.
There are three different uncemented Acetabular Cup designs allowing for adjunct fixation; two with specifically designed screw hole patterns, and one with protruding "spurs" designed to fixate to the previously prepared acetabular surface. The Ti6Al4V Acetabular Cups are CpTi plasma spray coated on the trabecular surface. The Ti6A14V Acetabular Screws are available in 6 lengths from 15 to 40mm in 5mm increments.
The conventional non-cross-linked UHMWE Acetabular Liners are available in various diameters corresponding to the Femoral Heads and Acetabular Cups, and in 10 degree elevated and standard, non-elevated rim configurations.
Intended Use [21 CFR 807.92(a)(5)]
The Excera Orthopedics Total Hip Arthroplasty System is intended to be used for total hip replacement in skeletally mature individuals.
The System's modular design provides a large selection of component sizes, allowing implant geometry to be optimized.
5
FitRite™ Total Hip Arthroplasty System
Indications for Use:
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
Certain cases of ankylosis.
The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.
Technological Characteristics [21 CFR 807.92(a)(6)]
The Excera FitRite™ Total Hip Arthroplasty System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy.
Non-clinical testing [21 CFR 807.92(b)(1)]
Testing in accordance with ASTM/ISO standards was used to evaluate mechanical performance. A summary of tests performed, results, and standards used is given below in table 5.1
In addition, coating characterization testing was performed on the subject device.
| Standard | Test Type | Results |
|---|---|---|
| ASTM F2068 | Proximal Fatigue | Pass |
| ISO 7206-4:2010 | Distal Fatigue | Pass |
| ISO 21535:2007 | Range of Motion | Pass |
| ASTM F1875 | Taper Fretting | Pass |
| ASTM F2009 | Femoral Head Distraction | Pass |
| ASTM F1820 | Liner Push out, Lever out & Torque out | Pass |
| ASTM F543 | Screw Insertion Torque & Max Torque | Pass |
Table 5.1: Testing Summary for The Excera FitRite™ Total Hip Arthroplasty System
6
FitRite™ Total Hip Arthroplasty System
Clinical testing [21 CFR 807.92(b)(2)]
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification
Conclusions [21 CFR 807.92(b)(3)]
Based on the information provided in this premarket notification, we believe that the subject Excera FitRite™ Total Hip Arthroplasty System demonstrates substantial equivalence to the identified predicate devices.