(154 days)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Fractures of the femoral neck or head.
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to prosthesis.
The proposed subject device is a line extension to the acetabular cup system previously cleared in K103384. The predicate is a modular system intended for the replacement of the natural articular surface of the hip joint in total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The subject and predicate acetabular liners are both made of highly cross-linked polyethylene and are hemispherical in shape with positive locking, liner stabilization, and anti-rotation features.
The Legend Acetabular Liners (subject device) differ from the predicate device, cleared in K103384, through the addition of new sizes. Other components of the system have not been modified and are not a part of this submission other than by reference.
This document is a 510(k) premarket notification for the Legend® Acetabular Liners. It is a submission for a medical device and, as such, does not involve studies related to AI, image interpretation, or human-in-the-loop performance. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing of a physical medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impingement Performance per ASTM F-2582 | Met predetermined acceptance criteria. |
| Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011 | Met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the non-clinical tests (impingement performance and bacterial endotoxin testing). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective, though for non-clinical lab testing of a physical device, these provenance details are less commonly reported in summary documents.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The "ground truth" in this context refers to the performance standards set by ASTM and ANSI/AAMI for the physical properties of the device, not expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a physical device performance test, not an interpretive one requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a medical device, specifically an orthopedic implant, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by the specified industry standards and methodologies: ASTM F-2582 for Impingement Performance and ANSI/AAMI ST72:2011 for Bacterial Endotoxin Testing. These are objective engineering and microbiological performance standards.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 30, 2018
Ortho Development Corporation Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K173951
Trade/Device Name: Legend® Acetabular Liners 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, LZO Dated: April 30, 2018 Received: May 1, 2018
Dear Drew Weaver:
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 (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 (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -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) K173951
Device Name Legend® Acetabular Liner
Indications for Use (Describe)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- · Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- · Previously failed hip surgery.
- · Fractures of the femoral neck or head.
- · Avascular necrosis of the femoral head.
- · Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to prosthesis.
| Type of Use (Select one or both, as applicable) | Depository Institution (31 CFR 221 Subpart D) Securities Intermediary (31 CFR 221 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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}------------------------------------------------
12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com
K173951 Page 1/2
Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo is purple and features a stylized circle with curved lines emanating from it on the left. To the right of the circle is the word "ORTHO" in capital letters, and below that is the word "DEVELOPMENT" in smaller letters.
Section 5 510(k) Summary
| Name of Sponsor: | Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020 |
|---|---|
| 510(k) Contact: | Drew WeaverDirector of Quality Assurance and Regulatory AffairsTelephone: (801) 619-3419Facsimile: (801) 553-9993Email: DWeaver@orthodevelopment.com |
| Date Prepared: | May 24, 2018 |
| Proprietary Name: | Legend® Acetabular Liner |
| Common Name: | Acetabular Liner Prosthesis |
| Classification: | 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Device Class: | Class II device |
| Device Product Code: | LPH, LZO |
| Predicate Devices: | K103384 – Acetabular Cup SystemOrtho Development Corporation |
5.1 Device Description
The proposed subject device is a line extension to the acetabular cup system previously cleared in K103384. The predicate is a modular system intended for the replacement of the natural articular surface of the hip joint in total hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The subject and predicate acetabular liners are both made of highly cross-linked polyethylene and are hemispherical in shape with positive locking, liner stabilization, and anti-rotation features.
The Legend Acetabular Liners (subject device) differ from the predicate device, cleared in K103384, through the addition of new sizes. Other components of the system have not been modified and are not a part of this submission other than by reference.
{4}------------------------------------------------
5.2 Indications for Use
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic 1. arthritis.
-
- Previously failed hip surgery.
-
- Fractures of the femoral neck or head.
-
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to 5. properly seat the prosthesis.
5.3 Basis for Substantial Equivalence:
The Legend Acetabular Liners have the same technological characteristics as the predicate devices. These include:
- Indications for use
- Intended Use
- Fundamental design
- Material
- Manufacturer
- Manufacturing Processes
- Sterilization
- Packaging
The following non-clinical tests were conducted on various configurations of the Legend Acetabular Liners and met the predetermined acceptance criteria:
- lmpingement Performance per ASTM F-2582
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
The fundamental scientific technology of the Legend Acetabular Liner is the same as the previously cleared predicate device. The mechanical test results demonstrate that the Legend Acetabular Liners are as safe, as effective, and perform as well as or better than the legally marketed device predicate. No clinical studies were performed.
Based on similarities in intended use, design, manufacturing methods, sterilization, packaging, and the mechanical test results, the Legend Acetabular Liner is substantially equivalent to the predicate device that was cleared under K103384.
§ 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.