(22 days)
Not Found
No
The document describes a physical implant (acetabular shell) and its material properties and testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is an acetabular shell prosthesis used in total hip arthroplasty to treat impaired hip joints, thus providing a therapeutic benefit by restoring joint function.
No
Explanation: This device is an acetabular shell, which is an orthopedic implant used in total hip arthroplasty to replace a damaged hip joint. Its purpose is therapeutic (restoring function), not diagnostic (identifying a condition).
No
The device description clearly describes a physical implant (acetabular shell) made of titanium alloy with a porous coating, designed for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty, which is a surgical procedure involving the replacement of a joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (acetabular shell) made of titanium alloy, designed to be surgically implanted into the hip joint. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the mechanical properties of the implant (shear strength, tensile strength) and its adherence to orthopedic implant standards. IVD performance studies would typically involve evaluating the accuracy, precision, sensitivity, and specificity of a test in detecting a particular analyte or condition in biological samples.
In summary, the Legend® Acetabular Shell is a surgical implant used for treatment, not a device used to perform diagnostic tests on in vitro samples.
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 stock exists to properly seat the prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.
The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.
The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joints
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The coating from the new supplier was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.
The new coating from Avalign Thortex meets the requirements of FDA Guidance: Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994.
The coating material is commercially pure Titanium per ASTM F1580.
It meets the design specifications listed in 21 CFR 888.3358.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Shear strength >2,900 psi per ASTM F1044.
Tensile Strength >2,900 psi per ASTM F1147
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2024
Ortho Development Corp. Drew Weaver Director of Regulatory Affairs 12187 S. Business Park Drive Draper, Utah 84020
Re: K242833
Trade/Device Name: Legend® Acetabular Shell 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: September 11, 2024 Received: September 19, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242833
Device Name Legend® Acetabular Shell
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 stock exists to properly seat the prosthesis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/2 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three curved lines emanating from the left side, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in smaller, gray letters.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Name of the Sponsor: | Ortho Development® Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Name: Drew Weaver
Position: Director of Regulatory Affairs
Address: 12187 S. Business Park Drive
Draper, UT 84020 USA
Telephone: (801) 553-9991
Email: dweaver@orthodevelopment.com |
| Date Prepared: | October 10, 2024 |
| Submission Type: | Special |
| Proprietary Name: | Legend® Acetabular Shell |
| Common Name: | Acetabular Shell |
| Product Code /
Classification: | LPH Prosthesis, hip, semi-constrained, metal/polymer,
porous uncemented
21 CFR 888.3358: Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented
prosthesis |
| Associated Product
Code(s) / Classification: | LZO Prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented
21 CFR 888.3353: Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented
prosthesis |
| Device Class: | Class 2 |
| Primary Predicate
Device: | Ortho Development Escalade Legend® Acetabular Shell
(K161080) |
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Image /page/5/Picture/2 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three curved lines emanating from the top left, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, gray font with a star symbol.
1.0 Device Description:
The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.
The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.
The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.
2.0 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 properly seat the prosthesis.
3.0 Comparison of Technological Characteristics:
The purpose of this 510(k) is to add an additional supplier of commercially pure titanium sintered coating. The K161080 device has the same type of coating but applied by a different supplier.
The subject Legend® Acetabular Shells are identical to the predicate Escalade Legend® Acetabular Shells from K161080 in all other ways.
No other changes are made to this device.
The indication for use/intended use, technological characteristics, basic design, device material, and principles of operation are unchanged.
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Image /page/6/Picture/1 description: The image shows the text 'K242833' on the first line and 'Page 3 of 3' on the second line. The text is in a simple, sans-serif font and is horizontally aligned. The image appears to be a page number indicator, possibly from a larger document.
Image /page/6/Picture/2 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three curved lines emanating from the left side, followed by the word "ORTHO" in purple block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in smaller, gray letters with a registered trademark symbol.
The coating from the new supplier was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.
4.0 Performance Data:
The new coating from Avalign Thortex meets the requirements of FDA Guidance: Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994.
The coating material is commercially pure Titanium per ASTM F1580.
Shear strength >2,900 psi per ASTM F1044.
Tensile Strength >2,900 psi per ASTM F1147
It meets the design specifications listed in 21 CFR 888.3358.
5.0 Other Considerations:
Aside from the additional coating supplier, no other changes to the device have been made. The sterilization, packaging, shelf life, and materials are identical to the predicate. Minor editorial changes have been made to the labeling.
6.0 Substantial Equivalence Conclusion:
Verification and validation has been conducted according to design control procedures within a risk analysis framework to determine that the design outputs meet the design inputs using the same test criteria and methodology as the predicate K161080.
Based on similarities in indication for use/intended use, technological characteristics, basic design, device material, and principle of operation, the Legend® Acetabular Shell is considered substantially equivalent to the previously cleared predicate device.