(154 days)
Not Found
No
The summary describes a mechanical implant (acetabular liners) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities. The changes are limited to new sizes of an existing device.
No
The device, an acetabular liner, is a prosthetic implant used for joint replacement, which is a restorative rather than therapeutic function.
No
The device description indicates it is a line extension to an acetabular cup system used in total hip replacement surgery, consisting of components like shells and liners. Its purpose is to replace the natural articular surface of the hip joint. This is a therapeutic/prosthetic device, not one designed to diagnose a condition.
No
The device description clearly states it is a line extension to an acetabular cup system, consisting of physical components like liners made of polyethylene. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in total hip arthroplasty, which is a surgical procedure to replace the hip joint. This is a treatment, not a diagnostic test performed on samples from the body.
- Device Description: The description details components of a hip replacement system (acetabular shells, liners, screws, etc.). These are implantable medical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. The performance studies focus on mechanical properties and bacterial endotoxin, not diagnostic accuracy metrics like sensitivity or specificity.
This device is a surgical implant used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
LPH, LZO
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.
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
Not Found
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
The following non-clinical tests were conducted on various configurations of the Legend Acetabular Liners and met the predetermined acceptance criteria:
- Impingement Performance per ASTM F-2582
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
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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.
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12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com
K173951 Page 1/2
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Section 5 510(k) Summary
| Name of Sponsor: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Drew Weaver
Director of Quality Assurance and Regulatory Affairs
Telephone: (801) 619-3419
Facsimile: (801) 553-9993
Email: 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-constrained
porous-coated uncemented prosthesis
21 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 System
Ortho 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.
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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.