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

K163497 · Encore Medical L.P. · KWZ · Mar 2, 2017 · Orthopedic

Device Facts

• Record ID: K163497
• 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
• Applicant: Encore Medical L.P.
• Product Code: KWZ · Orthopedic
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

EXPRT™ Revision Hip System consists of non-porous distal femoral stem implants, proximal body implants, and capture bolts; all manufactured from titanium alloy (Ti6Al4V). Used by orthopedic surgeons in clinical settings for revision hip arthroplasty. System includes specialized instrumentation for bone preparation. Device provides structural support for patients with compromised femoral bone stock. Subject device expands compatibility to include all DJO Surgical femoral head configurations, unlike the predicate which was limited to -4 offset heads.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical fatigue testing and endotoxin assessment.

Technological Characteristics

Materials: Titanium alloy (Ti6Al4V) per ASTM F1472. Components: Non-porous distal femoral stem, proximal body implants, capture bolt. System is a modular hip prosthesis for revision arthroplasty.

Indications for Use

Indicated for patients with poor bone stock or inadequate bone for standard reconstruction due to femoral head, neck, or proximal femur deficiencies. Intended for cementless revision hip arthroplasty.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• EXPRT Revision Hip System (K161610)

Submission Summary (Full Text)

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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 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

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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<br>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<br>reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is<br>intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants. |
| Type of Use (Select one or both, as applicable) | |
| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label><br><label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 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: [phone] Fax: [phone] Email: [e-mail]

| Trade Name | Common Name | Classification | Product Codes |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------|---------------|
| EXPRT™ Revision Hip System - EXPRT™ Hip Distal<br>Stem, EXPRT™ Hip Standard Offset Proximal Body<br>Implant, EXPRT™ Hip Lateral Offset Proximal Body<br>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<br>888.3310 |
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented<br>prosthesis per 21 CFR 888.3353 |
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR<br>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.