(79 days)
Not Required
No
The summary describes a mechanical implant system and instrumentation, with no mention of software, algorithms, or AI/ML terms.
Yes
Explanation: The device is indicated for hip arthroplasty to treat deficiencies of the femoral head, neck, or proximal femur, which makes it a therapeutic device.
No
Explanation: The device is a hip implant system used for surgical revision of the hip, not for diagnosing medical conditions. Its purpose is to replace parts of the femur.
No
The device description explicitly states that the system includes physical implants made from titanium alloy and system-specific instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant for hip revision surgery. It is used to replace or reconstruct parts of the femur.
- Device Description: The description details a system of metal implants and instrumentation used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing purposes.
This device is a surgical implant used directly in the patient's body during a surgical procedure.
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 (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: Bacterial endotoxin testing is equivalent to the previously cleared system.
Clinical Testing: Clinical testing was not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 888.3310 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758
Re: K163497
Trade/Device Name: EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem. EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt 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: December 21, 2016 Received: December 22, 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
1
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 the quality systems (QS) 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.
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K163497 |
| Device Name | EXPRTT™ Revision Hip System - EXPRTT™ Hip Distal Stem, EXPRT™™ Hip Standard Offset Proximal Body Implant, EXPRT™™ Hip
Lateral Offset Proximal Body Implant, EXPRT™™ Hip Capture Bolt |
| Indications for Use (Describe) | EXPRTT™ 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.
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."
FORM FDA 3881 (8/14) TO BE COMPLETED. PLEASE REVIEW AND SUBMIT AGAIN. THANK YOU.
3
510(k) Summary
Date: February 28, 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@djosurgical.com
| Trade Name | Common Name | Classification | Product Codes |
|---|---|---|---|
| EXPRT™ Revision Hip System - EXPRT™ Hip Distal | |||
| Stem, EXPRT™ Hip Standard Offset Proximal Body | |||
| Implant, EXPRT™ Hip Lateral Offset Proximal Body | |||
| Implant, EXPRT™ Hip Capture Bolt | Revision Hip Implant | Class II | KWZ, LZO, LWJ |
| Product Code | Regulation and Classification Name |
|---|---|
| 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.
EXPRT Revision Hip System – K161610 Predicate Devices:
Comparable Features to Predicate Device is comparable to the predicate devices in indications, material, design features, dimensions, surgical implantation technique, intended use, packaging, and sterilization.
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Key Differences in Subject Device to Predicate: The key difference between the subject device and the predicate device is the use of compatible components. The predicate device only allowed use with -4 offset femoral heads. The subject device will allow all configurations of DJO Surgical femoral heads.
Non-Clinical Testing: Fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Endotoxin Assessment: Bacterial endotoxin testing is equivalent to the previously cleared system.
Clinical Testing: Clinical testing was not required
Conclusion: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.