(147 days)
No
The document describes a mechanical joint replacement system and does not mention any AI or ML components or functionalities.
No.
This device is an artificial joint component, specifically an acetabular system for total hip replacement, which is a prosthetic device used to replace damaged body parts, not to treat or cure a disease or condition in the way a therapeutic device would.
No
This device is a medical implant (acetabular system for joint replacement), not a diagnostic tool. Its purpose is to replace anatomical structures, not to identify or characterize diseases or conditions.
No
The device description clearly outlines physical components (porous coated titanium acetabular cups, bone screws, acetabular liners) and mechanical testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for joint replacement, specifically the acetabulum. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical implant (acetabular cups, screws, liners) designed to be surgically placed in the body. IVDs are typically reagents, instruments, or systems used to examine specimens.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing and endotoxin assessment, which are relevant to the safety and function of a surgical implant, not the accuracy of a diagnostic test.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is to replace a damaged joint, which is a treatment, not a diagnosis.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis:
- · correction of functional deformity;
- · femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is indicated for cementless use.
Product codes
LPH, OQG
Device Description
The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (Hip joint)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Range of Motion Analysis
- Impingement Testing
- Push Out, Lever Out, and Torsional Strength
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072888, K130365, K172651, K931665, K121874, K040412
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
June 07, 2019
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K190057
Trade/Device Name: DJO Acetabular 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, OQG Dated: January 10, 2019 Received: January 11, 2019
Dear Teffany Hutto:
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. 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 located 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
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; 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 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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190057
Device Name DJO Acetabular System
Indications for Use (Describe)
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis:
- · correction of functional deformity;
- · femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is indicated for cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
510(k) Summary
Date: June 7, 2019
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (760) 597-3466 Email: teffany.hutto@djoglobal.com
| Product | Common Name | Classification | Product Code |
|---|---|---|---|
| DJO Acetabular System | Total Hip Implant | Class II | LPH, OQG |
| Product Code | Regulation and Classification Name |
|---|---|
| LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 |
| CFR 888.3358 | |
| OQG | Hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
| per 21 CFR 888.3358 |
Description:
The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular ● necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture. .
This device may also be indicated in the salvage of previously failed surgical attempts. This device is indicated for cementless use.
Predicate Devices:
| System Name | Manufacturer | 510(k) Clearance |
|---|---|---|
| FMP Hemispherical Acetabular Shells | Encore Medical, L.P. | K072888 |
| FMP HXe+ Acetabular Liner | Encore Medical, L.P. | K130365 |
| FMP HXe+ Extended Acetabular Liner | Encore Medical, L.P. | K172651 |
| Cancellous Bone Screws | Encore Medical, L.P. | K931665 |
| G7 Acetabular System | Biomet | K121874 |
| Trident Acetabular System | Stryker | K040412 |
4
Comparable Features to Predicate Device(s):
K190057 p. 2/2
Acetabular Cup: Materials, size offering, style offering, key material thickness, porous coating, outer diameter, internal surface finish, anti-rotation feature, number of internal scallops, dome thread plug, screw hole options, screw hole layout, packaging, sterilization, manufacturing process.
Acetabular Liner: Material, size offering, number of scallops, minimum wall thickness, wear, impingement, poly locking feature, surface finish, sterilization, packaging, manufacturing process.
Bone Screw: Thread form and diameter, screw lengths, self tapping screw tip, surface finish, drive feature, material, sterilization, packaging, manufacturing process.
Implant Relationship: ROM, jump distance, poly liner locking mechanism, poly liner collar, poly liner articulating surface, bone screw angulation, bone screw drill preparation, titanium dome plug cover
Key Differences in Subject Device to Predicate:
There are no key differences between the subject device and predicate devices.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:
- Range of Motion Analysis
- Impingement Testing
- Push Out, Lever Out, and Torsional Strength
All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.
Clinical Testing: Clinical testing was not required
Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.