PS2 Knee System

K160515 · Consensus Orthopedics, Inc. · JWH · Dec 19, 2016 · Orthopedic

Device Facts

• Record ID: K160515
• Device Name: PS2 Knee System
• Applicant: Consensus Orthopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems. The indications for use are: - A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. - B. Failed osteotomy or unicompartmental replacements. - C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. - D. The PS2 KNEE SYSTEM is intended for cemented use.

Device Story

PS2 Knee System is a fixed-bearing total knee prosthesis; offers cruciate retaining (CR) or posterior stabilizing (PS) options. Components include femoral components, tibial baseplates, tibial inserts, and patellar components. Used in orthopedic surgery for total knee arthroplasty; implanted by surgeons in clinical/hospital settings. System utilizes modular keel for tibial fixation; compatible with previously cleared stems, taper plugs, and cancellous bone screws. Femoral components and baseplates are cast CoCr alloy; inserts and patellar components are UHMWPE or VitalitE. Device is intended for cemented use only. Provides mechanical restoration of knee joint function; helps alleviate pain and improve mobility in patients with degenerative or inflammatory joint disease.

Clinical Evidence

Bench testing only. Testing included fatigue testing of femoral components and baseplates (ASTM F1800-12), tibiofemoral and patellofemoral joint stability (ASTM F1223), joint contact characteristics (ASTM F2083-12), tibial insert locking mechanism strength, wear testing (ISO 14243-1), and PS post fatigue testing. All testing performed in accordance with FDA Class II Special Controls Guidance.

Technological Characteristics

Materials: Cast CoCr alloy (ASTM F75), UHMWPE (ASTM F648), VitalitE (ASTM F2695), Titanium alloy (ASTM F1472, ASTM F136). Design: Fixed-bearing, semi-constrained, cemented total knee prosthesis. Components: Femoral (CR/PS), tibial baseplate (pegged/pegless/holed), tibial insert (CR/PS), patellar (oval/round). Modular keel compatible with existing stems/plugs. No software or electronics.

Indications for Use

Indicated for patients requiring primary total knee arthroplasty due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, degenerative arthritis, failed osteotomy, failed unicompartmental replacement, or revision of unsatisfactory cemented/press-fit components with sufficient bone stock. Intended for cemented use only.

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

• Consensus Knee System, Line Extensions (K110950)
• Consensus Knee System - Primary Knee (K932837)
• Consensus Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate (K945589)
• Genesis II Knee System (K951987)
• Consensus Posterior Stabilized Knee (K954818)
• Genesis II Constrained System (K962137)
• Consensus Knee System; Tibial Baseplate, Cast, CoCr/Ti Porous and CoCr Non-Porous (K001456)
• Consensus Revision Knee System (K100542)
• VitalitE Tibial Insert & Patellar Components (K133919)
• Consensus Knee System Modular Tibial Baseplate (K143725)

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a design that resembles an eagle or bird in flight above them.

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

December 19, 2016

Consensus Orthopedics, Inc. Zac Johnson Regulatory Affairs Manager 1115 Windfield Way, Ste 100 El Dorado Hills, California 95762

Re: K160515 Trade/Device Name: PS2 Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: November 11, 2016 Received: November 14, 2016

Dear Zac Johnson:

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. Isting 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 [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 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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#### 1. INDICATIONS FOR USE STATEMENT

K160515 510(k) Number (if know):

Device Name: PS2 Knee System

#### INDICATIONS AND USAGE:

The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

- A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- B. Failed osteotomy or unicompartmental replacements.
- C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- D. The PS2 KNEE SYSTEM is intended for cemented use.

Prescription Use X (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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### 2. 510(k) SUMMARY

| Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Name: Zac Johnson<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | 19 February 2016 |
| Trade Name: | PS2 Knee System |
| Common Name: | PS2 Total Knee System |
| Classification Name: | Knee joint patellofemorotibial Polymer/metal/polymer semi-<br>constrained cemented prosthesis is a Class 2 device per 21 CFR<br>888.3560 (Product Code JWH/OIY) |

# Device Description:

The PS2 Knee System is a primary fixed bearing total knee system offering flexibility to restore knee function using either cruciate retaining (CR) or posterior stabilizing (PS) components with the option of tibial cancellous screw and tibial stem fixation. The uncoated femoral components (CR and PS) and uncoated tibial baseplates (pegged, pegless, and holed) are made from cast CoCr alloy (ASTM F75), and are intended for cemented use only. The tibial inserts (CR and PS) and all-poly patellar components (oval and round) are made from UHMWPE (ASTM F648) or VitalitE (ASTM F2695). The PS2 tibial baseplate employs a modular keel, which is compatible with the previously cleared Consensus Revision Knee System (CRKS) stem and taper plug made from Titanium alloy (ASTM F1472). The PS2 holed baseplate is compatible with the previously cleared Consensus Knee System (CKS) 6.5mm cancellous bone screw made from Titanium alloy (ASTM F136). The PS2 baseplate is supplied with four preassembled cement dams made from UHMWPE and supplied with a distal plug made from UHMWPE intended for assembly in the operating room when stems are not desired.

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## Indications for Use:

The PS2 KNEE SYSTEM is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

- A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- B. Failed osteotomy or unicompartmental replacements.
- C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
- D. The PS2 KNEE SYSTEM is intended for cemented use.

# Substantial Equivalence:

# Technological Characteristics/ Substantial Equivalence:

Consensus Orthopedics, Inc. (COI) asserts the PS2 implant components to be substantially equivalent to legally marketed predicate devices regarding their indications for use, technology, and performance (Table 6.1). The PS2 cruciate retaining (CR) femoral component is substantially equivalent to the Consensus Knee System (CKS) Reduced Lateral Profile (RLP) uncoated CR femoral component (K110950). The PS2 posterior stabilized (PS) femoral component is substantially equivalent to the CKS RLP uncoated PS femoral component (K110950). The PS2 CR tibial insert is substantially equivalent to the CKS congruent tibial insert made from standard UHMWPE (K932837, K110950) or VitalitE (K133919). The PS2 PS tibial insert is substantially equivalent to the CKS PS tibial insert made from standard UHMWPE (K954818, K110950). The 25mm PS2 tibial inserts are substantially equivalent to the 25mm Genesis II PS tibial insert (Smith & Nephew, K951987). The 30mm PS2 tibial inserts are substantially equivalent to the 30mm Genesis II PS constrained tibial insert (Smith & Nephew, K962137). The PS2 baseplate is substantially equivalent to the CKS modular baseplate (K143725), the CKS uncoated CoCr baseplate (K945589, K001456, K110950), and the Consensus Revision Knee System (CRKS) baseplate (K100542). The PS2 oval and round patellar components are substantially equivalent to the CKS oval and round all-poly patellar components made from standard UHMWPE (K932837) or VitalitE (K133919). As with the PS2 femoral components, tibial baseplate, and patella components; the corresponding predicate devices are intended for cemented use.

All implant devices compatible with the PS2 Knee System are legally marketed in the US (Table 6.2). The distal plug intended for use with the PS2 baseplate was previously cleared for use with the CKS modular baseplate (K143725). The CRKS stem and CRKS taper plug intended for use with the PS2 baseplate were previously cleared for use with the CKS modular baseplate (K143725) and the CRKS baseplate (K100542). The 6.5mm cancellous bone screw intended for use with the PS2 baseplate was previously cleared for use with the CKS modular baseplate (K143725) and the CKS uncoated CoCr baseplate (K945589). The cement dam intended for use with the PS2 holed baseplate was previously cleared for use with the CKS modular baseplate (K143725) and the CKS uncoated CoCr baseplate (K945589).

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| Primary Vs<br>Secondary<br>Predicate | Component Name | 510(k)<br>Number | 510(k)<br>Trade Name | 510(k)<br>holder | 510(k)<br>Release Date |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------|------------------------|
| Primary | CKS RLP uncoated<br>CR femoral<br>component;<br>CKS RLP uncoated<br>PS femoral<br>component;<br>CKS congruent CR<br>tibial insert (20,<br>22mm);<br>CKS PS tibial insert<br>(20, 22mm);<br>CKS uncoated CoCr<br>baseplate (size 0) | K110950 | Consensus® Knee<br>System, Line<br>Extensions; Total knee<br>prosthesis for cemented<br>or uncemented use | COI | 6/27/2011 |
| Secondary | CKS congruent CR<br>tibial insert (10-<br>18mm);<br>CKS all-poly<br>patellar component<br>(oval/round) | K932837 | Consensus Knee System<br>- Primary Knee | COI | 9/27/1994 |
| Secondary | CKS uncoated CoCr<br>baseplate<br>(pegged w/ holes) | K945589 | Consensus® Knee<br>Cobalt Chrome<br>Nonporous Stemmed<br>Tibial Baseplate | COI | 5/31/1995 |
| Secondary | Genesis II PS tibial<br>insert (9-25mm) | K951987 | Genesis II Knee System | S&N | 8/22/1995 |
| Secondary | CKS PS tibial insert<br>(10-18mm) | K954818 | Consensus Posterior<br>Stabilized Knee | COI | 5/22/1996 |
| Secondary | Genesis II PS<br>Constrained tibial<br>insert (9-30mm) | K962137 | Genesis II Constrained<br>System | S&N | 8/2/1996 |
| Secondary | CKS uncoated CoCr<br>baseplate<br>(pegged w/o holes;<br>pegless w/o holes) | K001456 | Consensus® Knee<br>System; Tibial<br>Baseplate, Cast,<br>CoCr/Ti Porous and<br>CoCr Non-Porous | COI | 8/7/2000 |
| Secondary | CRKS baseplate | K100542 | Consensus Revision<br>Knee System | COI | 6/24/2010 |
| Secondary | CKS congruent CR<br>tibial insert;<br>CKS all-poly<br>patellar component<br>(oval/round) | K133919 | VitalitE Tibial Insert &<br>Patellar Components | COI | 7/14/2014 |
| Secondary | CKS modular<br>baseplate | K143725 | Consensus Knee System<br>Modular Tibial<br>Baseplate | COI | 3/4/2015 |
| Component Name | 510(k)<br>Number | 510(k)<br>Trade Name | 510(k)<br>holder | 510(k)<br>Release Date | |
| 6.5mm cancellous bone screw1;<br>Cement dam2 | K945589 | Consensus® Knee Cobalt Chrome<br>Nonporous Stemmed Tibial Baseplate | COI | 05/31/1995 | |
| CRKS stem;<br>CRKS taper plug | K100542 | Consensus Revision Knee System | COI | 06/24/2010 | |
| Distal plug | K143725 | Consensus Knee System Modular<br>Tibial Baseplate | COI | 03/04/2015 | |

Table 6.1: Legally marketed devices for which the PS2 implant components demonstrate substantial equivalence.

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Table 6.2: Legally marketed devices compatible with the PS2 Knee System.

Notes: (1) Bone screws were originally cleared under K922561 for use with Consensus Hip System acetabular components and later cleared under K945589 for use with the predicate CKS CoCr baseplate; (2) Cement dams were originally cleared under K945589 for use with the predicate CKS CoCr baseplate.

## Non-Clinical Performance Data:

Bench testing was carried out on PS2 implant components to verify their safety and effectiveness for clinical use. The femoral component was tested to ensure its backside box profile (tensile side) would not fail under fatigue when loaded in a manor to wedge the femoral component onto the femur. The baseplate tray region was tested per ASTM F1800-12 to ensure the tray would not fail under fatigue when one compartment collapses. Tibiofemoral joint stability was tested per ASTM F1223-12 (torsion) and -14 (translation). Patellofemoral joint stability was tested per the FDA's Class II Special Controls Guidance. Joint contact characteristics were tested per ASTM F2083-12 and FDA's Class II Special Controls Guidance to ensure adequate tibiofemoral and patellofemoral contact area and contact stresses under physiologic loading. The tibial insert locking mechanism was tested per FDA's Class II Special Controls Guidance to ensure adequate connection strength and ease of insertion. Wear testing was performed on the PS2 tibiofemoral articulation per ISO 14243-1. PS2 PS post fatigue testing was performed in compliance with FDA's Class II Special Controls Guidance. Testing the modular junctions with all previously cleared components (i.e. IM stem) was deemed unnecessary due to consistency in design.