Rebel 3DKNEE System

K143242 · Encore Medical L.P. · JWH · May 15, 2015 · Orthopedic

Device Facts

• Record ID: K143242
• Device Name: Rebel 3DKNEE System
• Applicant: Encore Medical L.P.
• Product Code: JWH · Orthopedic
• Decision Date: May 15, 2015
• 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. This device is intended to be used for cemented applications.

Device Story

Rebel 3DKNEE System is a total knee replacement prosthesis; line extension to existing 3DKNEE system. Components include non-porous distal femoral implants, tibial inserts, and tibial base implants. Intended for cemented surgical implantation by orthopedic surgeons to restore joint function in patients with severe knee disability. Device replaces damaged articular surfaces; restores joint configuration; addresses deformities. Benefits include pain relief and improved mobility for patients with arthritis, necrosis, or post-traumatic joint loss.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, specifically Finite Element Analysis (FEA) evaluating load conditions, patella subluxation, contact area, and contact stress.

Technological Characteristics

Total knee prosthesis. Materials: Cast CoCr alloy (ASTM F75) for femoral and tibial base implants; Highly Cross-Linked Vitamin E (HXL VE) UHMWPE for tibial inserts. Semi-constrained design. Intended for cemented application. No active energy source or software.

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 (with patellofemoral erosion, dysfunction, or prior patellectomy); moderate valgus, varus, or flexion deformities; or fractures unmanageable by other techniques. Also indicated for salvage of failed surgical attempts. For cemented use.

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

• 3DKNEE System (K020114, K091956)
• Foundation Knee System (K923277)
• Foundation PS Knee System (K933539)
• Movation Knee System (K100900, K121727)

Submission Summary (Full Text)

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May 15, 2015

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

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

Re: K143242 Trade/Device Name: Rebel 3DKNEE System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: April 10, 2015 Received: April 13, 2015

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

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Page 2 - Ms. Teffany Hutto

(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 (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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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### Indications for Use

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

510(k) Number (if known) K143242

Device Name Rebel 3DKNEE System

Indications for Use (Describe)

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. This device is intended to be used for cemented applications.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☒</span><span>Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span><span>Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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## 510(k) Summary

Date: May 7, 2015

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 |
|------------------------|-----------------------------------------------------------------------------------------------------------|---------------|--------------|-----------------------------------------------------------------------------------------------------------|
| Rebel TM 3DKNEE 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 REBEL™ 3DKNEE SYSTEM is a line extension to the current 3DKNEE system. It is a total knee system that includes non-porous distal femoral implants made from cast CoCr alloy per ASTM F75, tibial insert implants made from Highly Cross-Linked with Vitamin E (HXL VE) UHMWPE, and tibial base implants made from cast CoCr alloy per ASTM F75.

#### 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. This device is intended to be used for cemented applications.

| Predicate Devices: | 3DKNEE System - K020114 & K091956 |
|--------------------|------------------------------------------|
| | Foundation Knee System - K923277 |
| | Foundation PS Knee System - K933539 |
| | Movation Knee System - K100900 & K121727 |

Comparable Features to Predicate Device is comparable to the current 3DKNEE System in indications, material, dimensions, surgical implantation technique, and intended use. This device has the same implant packaging and sterilization as the 3DKNEE System.

Non-Clinical Testing: FEA to assess load conditions, patella subluxation, contact area/contact stress, tibial-femoral contact area, and tibial-femoral subluxation testing has determined that the device is substantially equivalent to the predicate devices.

Clinical Testing: None provided.