(152 days)
No
The document describes a mechanical implant system and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a hip implant intended for revision hip arthroplasty, which is a medical procedure to treat deficiencies of the femoral head, neck, or portions of the proximal femur, aligning with the definition of a therapeutic device.
No.
The device description indicates it is a revision hip system (implants and instrumentation) intended for surgical implantation rather than for diagnosing conditions.
No
The device description explicitly states that the system includes physical implants (distal femoral stem implants and proximal body implants) made from titanium alloy, as well as system-specific instrumentation. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the EXPRT™ Revision Hip System includes implants (femoral stem and proximal body) made from titanium alloy. These are surgically implanted devices.
- Intended Use: The intended use is for revision hip arthroplasty, which is a surgical procedure to replace a previously implanted hip joint. This involves implanting the device directly into the patient's body.
The information provided describes a surgical implant system, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Product codes
KWZ, LZO, LWJ
Device Description
The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, neck or portions of the proximal femur
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: ROM testing and distal fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.
Clinical Testing: Clinical testing was not required
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2016
DJO Surgical (Legal Name: Encore Medical, L.P.) Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K161610 Trade/Device Name: EXPRT™ Revision Hip System Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWZ, LZO, LWJ Dated: October 6, 2016 Received: October 13, 2016
Dear Ms. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number ( if known ) | K161610 |
|---|---|
| Device Name | EXPRT™ Revision Hip System |
| Indications for Use ( Describe ) | Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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510(k) Summary
Date: November 9, 2016
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@djosurgical.com
| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| EXPRTTM Revision Hip System | Class II | KWZ, LZO, LWJ | KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR |
| 888.3310 | ||||
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented | |||
| prosthesis per 21 CFR 888.3353 | ||||
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR | |||
| 888.3360 |
Description:
The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.
Indications for Use:
Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
| Predicate Devices: | DJO Modular Revision Hip System – K092331 |
|---|---|
| DJO TaperFill Hip Stem – K130099 | |
| Stryker Restoration Modular Revision Hip System – K050138 |
Comparable Features to Predicate Device is comparable to the predicate devices in indications, material, design features, surgical implantation technique, intended use, packaging, and sterilization.
Key Differences in Subject Device to Predicate: The subject hip stem features different dimensions and a distal-anterior relief at the bottom taper of the stem that is not present on the cleared predicates referenced in this 510(k).
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Non-Clinical Testing: ROM testing and distal fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.
Clinical Testing: Clinical testing was not required
Conclusion: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.