EMPOWR PS Knee System

K160342 · Encore Medical L.P. · JWH · May 19, 2016 · Orthopedic

Device Facts

• Record ID: K160342
• Device Name: EMPOWR PS Knee System
• Applicant: Encore Medical L.P.
• Product Code: JWH · Orthopedic
• Decision Date: May 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Joint replacement is indicated for patients suffering from disability due to: degenerative, post-traumatic or rheumatoid arthritis; avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; moderate valgus, varus or flexion deformities; treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur which is intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Device Story

EMPOWR PS Knee System is a total knee arthroplasty line extension; provides prosthetic replacement for damaged knee joints. Components include non-porous distal femoral implants (cast CoCr alloy) and tibial inserts (HXL VE UHMWPE). Used in orthopedic surgery to restore mobility and reduce pain in patients with degenerative or traumatic joint conditions. Implants are typically cemented, with specific porous-coated options for cementless use. Surgeon performs implantation using standard orthopedic techniques. Device functions as a mechanical bearing surface to replace natural joint articulation. Benefits include pain relief and improved joint function. No software or electronic components involved.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including FEA assessments for condyle/flange/wedge loading and CAD/mechanical testing for range of motion, post fatigue, contact area, constraint, and lateral subluxation.

Technological Characteristics

Materials: Cast CoCr alloy (ASTM F75) and Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. Design: Semi-constrained cemented prosthesis. Features: Modified anterior cam position, coronal condylar radii, bearing spacing, femoral PS housing profile, posterior cam engagement, post jump height, and tibial insert post geometry. Sterilization: Same as predicate EMPOWR system.

Indications for Use

Indicated for patients with disability due to degenerative, post-traumatic, or rheumatoid arthritis; avascular necrosis of femoral condyle; post-traumatic loss of joint configuration (patellofemoral erosion/dysfunction/prior patellectomy); moderate valgus, varus, or flexion deformities; or fractures unmanageable by other techniques. Also indicated for salvage of failed surgical attempts.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• EMPOWR Knee System (K143242)
• Foundation PS Knee System (K933539)
• Movation Knee System (K100900 & K121727)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2016

Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K160342 Trade/Device Name: EMPOWR PS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: May 2, 2016 Received: May 3, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR 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 yours,

## 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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| Form Approved: OMB No. 0910-0120 | |
|-----------------------------------|--|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |

| 510(k) Number (if known) | K160342 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EMPOWR PS Knee System |
| Indications for Use (Describe) | Joint replacement is indicated for patients suffering from disability due to: <ul><li>degenerative, post-traumatic or rheumatoid arthritis;</li><li>avascular necrosis of the femoral condyle;</li><li>post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;</li><li>moderate valgus, varus or flexion deformities;</li><li>treatment of fractures that are unmanageable using other techniques.</li></ul> This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEET\u2122 Porous Coated Femur which is intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="checked" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> |
| | <div> <label><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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かして

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## 510(k) Summary

Date: May 6, 2016

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]

| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|-----------------------|-----------------------------------------------------------------------------------------------------------|---------------|--------------|-----------------------------------------------------------------------------------------------------------|
| EMPOWR PS Knee System | Class II | JWH, OIY | JWH | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis per 888.3560 |
| OIY | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis per 888.3560 | | | |

## Description:

The EMPOWR PS Knee System is a line extension to the current EMPOWR system (previously cleared as Rebel 3DKNEE System). It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75 and tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE.

## Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

- degenerative, post-traumatic or rheumatoid arthritis; ●
- . avascular necrosis of the femoral condyle;
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- moderate valgus, varus or flexion deformities;
- treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur which is intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

| Predicate Devices: | EMPOWR Knee System - K143242 |
|--------------------|------------------------------------------|
| | Foundation PS Knee System - K933539 |
| | Movation Knee System - K100900 & K121727 |

Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the EMPOWR Knee are no different technological characteristics from the predicate device.

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K160342 Page 2 of 2 Key Differences in Subject Device to Predicate: Anterior Cam Position within Intercondylar Housing, Values of Coronal Condylar Radii and Bearing Spacing, Femoral Component PS Housing Profile, Posterior Cam Engagement with Tibial Insert, Post Jump Height, Shape of Tibial Insert Post Section, Tibial Insert Post Coronal Profile, Tibial Insert Articular Geometry Conformity Ratio, and Values of Tibial Post Width.

Non-Clinical Testing: FEA assessments for PS femur condyle closing loads, PS femur flange closing loads, and PS femur wedge loading. CAD analysis was completed for range of motion, and testing was completed for post fatigue, contact area, constraint, and lateral subluxation. All testing has determined that the device is substantially equivalent to the predicate devices.

Clinical Testing: None provided.