(99 days)
No
The summary describes a traditional 510(k) for a line extension of an existing acetabular liner, focusing on material properties and mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a joint replacement component (acetabular liner), is intended to treat disability caused by various degenerative joint diseases and femoral fractures, aiming to correct functional deformity and salvage failed surgical attempts. These actions involve restoring function and alleviating medical conditions.
No
The device is a joint replacement component (acetabular liner) used for surgical treatment, not for diagnosing a condition. Its intended use describes the conditions for which joint replacement is indicated, not how the device itself diagnoses them.
No
The device description clearly states it is a "line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line," which are physical implants used in joint replacement surgery. The performance studies also describe physical testing (wear, impingement, push-out, etc.) of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for joint replacement surgery to address issues within the hip joint. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an acetabular liner and is part of a joint replacement system. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on these types of tests.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
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 to be used for uncemented applications.
Product codes
OQG, LPH
Device Description
This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-Clinical Testing: Testing performed includes wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009. All evaluations determined that the devices are substantially equivalent to the applicable predicate devices.
Clinical Testing: Clinical testing is not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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.
December 13, 2017
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K172651
Trade/Device Name: FMPTM Extended 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: OQG, LPH Dated: November 28, 2017 Received: November 29, 2017
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. 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);
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Page 2 - Teffany Hutto
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 medical devices and radiation-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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known) | K172651 |
|---|---|
| Device Name | FMPT™ Extended Liners |
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 to be used for uncemented applications.
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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င္ခင္မွ ခ်စ္ေ႕
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510(k) Summary
Date: September 1 , 2017
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: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| FMP Extended | ||
| Liners | Class II | 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:
This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.
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 to be used for uncemented applications.
Predicate Devices:
| Device | Manufacturer | 510(k) Number | 510(k) Type |
|---|---|---|---|
| X-alt Highly Cross Linked | |||
| Acetabular Liner with Vitamin E | Encore Medical, L.P. | K130365 | Primary |
| Stryker Trident Large Diameter | |||
| Acetabular Insert | Stryker | K062419 | Additional |
| Foundation® Porous Coated | |||
| Hemispherical Acetabular Cup | Encore Medical, L.P. | K974093 | Reference |
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Comparable Features to Predicate Device(s):
These components are comparable to the predicate devices in indications, material, design features, manufacturing methods, surgical implantation technique, intended use, packaging, and sterilization.
Key Differences in Subject Device to Predicate:
Collar height and liner thickness compared to K130365.
Bacterial endotoxin testing conducted based on DJO Surgical's Endotoxin Assessment: alternative to batch testing plan met the bacterial endotoxin limits defined in USP as evidenced through ongoing monitoring conducted concurrently with dose audits. Testing conducted with the most recent dose audit using the worst case product demonstrated an acceptable BET level. The subject FMP Extended Liners require fewer manufacturing operations and less handling than the worst case product (FMP Shell). Refer to NDPCAW-00085 for new product review.
Non-Clinical Testing: Testing performed includes wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009. All evaluations determined that the devices are substantially equivalent to the applicable predicate devices.
Clinical Testing: Clinical testing is not required.