VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT

K130652 · Consensus Orthopedics, Inc. · OQG · Dec 17, 2013 · Orthopedic

Device Facts

• Record ID: K130652
• Device Name: VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
• Applicant: Consensus Orthopedics, Inc.
• Product Code: OQG · Orthopedic
• Decision Date: Dec 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications: A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

Device Story

VitalitE Acetabular Insert is a vitamin E-stabilized (α-tocopherol) cross-linked UHMWPE liner for the CS2 Acetabular Cup System. Device functions as a bearing surface in total hip arthroplasty; mates with titanium alloy shells via a locking mechanism. Compatible with CoCr, zirconia, or Biolox delta femoral heads. Used in clinical settings by orthopedic surgeons for hip replacement procedures. Provides a wear-resistant bearing surface to restore joint function and mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Testing included wear testing of the worst-case acetabular insert, disassembly testing (push-out and torque-out), material characterization, and biocompatibility testing.

Technological Characteristics

Materials: Vitamin E (α-tocopherol) stabilized cross-linked UHMWPE (ASTM F648), titanium alloy shell (ASTM F620 or F136). Design: Neutral or hooded liners; standard or lateral offsets; 22mm, 32mm, and 36mm inner diameters. Fixation: Uncemented press-fit or cemented. Locking mechanism: Secure insert/shell interface.

Indications for Use

Indicated for patients with significantly impaired hip joints due to rheumatoid, osteo, or post-traumatic arthritis; failed prior hip procedures; proximal femoral fractures; avascular necrosis; non-union of femoral neck fractures; or structural/metabolic conditions (e.g., dysplasia, osteoporosis).

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Consensus CS2 Plus Acetabular Inserts (lateralized) (K100933)
• Consensus Hip System 36mm Femoral Head & Acetabular Insert (K070061)
• Cross Linked Polyethylene Acetabular Insert (K021466)
• Cross-Over Acetabular Shell and Liner (lateralized) (K122773)
• EXp Acetabular Shell Liner (K094035)
• Pipeline Total Hip System (K112802)

Submission Summary (Full Text)

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K130652

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## Page 1 of 3

## 2. 510(k) SUMMARY

# DEC 1 7 2013

| Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC<br>Phone: [phone]/ Fax: [phone]<br>[e-mail] |
| Date Prepared: | 16 December, 2013 |
| Trade Name: | VitalitE Acetabular Insert for the CS2™ Acetabular Cup System |
| Common Name: | Vitamin E Cross Linked Polyethylene, Acetabular Insert |
| Device Classification: | Class II |
| Classification(s): | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis: 21 CFR 888.3358, Product Codes LPH & OQG. |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis: 21 CFR 888.3353, Product Codes<br>LZO & OQI. |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:<br>21 CFR 888.3360, Product Code KWL. |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented<br>prosthesis: 21 CFR 888.3390, Product Code KWY. |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis:<br>21 CFR 888.3360, Product Code LWJ. |
| | Hip joint metal/polymer semi-constrained cemented prosthesis: 21 CFR<br>888.3350, Product Codes JDI & OQH. |
| | |

## Device Description:

The Consensus CS2™ Acetabular Cup System consists of a titanium alloy shell (ASTM F620 or F136) and a polyethylene liner (ASTM F648). The system is compatible with the femoral components of all cleared hip systems manufactured by Consensus Orthopedics, Inc.: Consensus Hip System (CHS), TaperSet Hip System (THS), CS2 Hip System (CS2HS), and UniSyn Hip System (UniSyn). The CS2 Acetabular Cup System can be used with the CoCr, zirconia, or Biolox delta femoral heads currently marketed by Consensus and with 22mm, 32mm, and 36mm inner diameters. The liners are available in either neutral or hooded versions and with either standard or lateral offsets. The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The

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## K130652

shell comes with or without holes for additional screw fixation. The new acetabular liners will be made from UHMPWE that contains vitamin E (a-tocopherol).

## Indications for Use:

The VitalitE Acetabular Insert for the Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:

A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use.

Consensus femoral stems are indicated for cemented and cementless use.

UniSyn. TaperSet, and CS2 femoral stems are indicated for cementless use only.

HA coated implants are indicated for cementless use only.

## Substantial Equivalence:

#### Technological Characteristics/ Substantial Equivalence:

The new VitalitE Acetabular Insert for the CS2 Acetabular Cup System is identical in design to the cross-linked UHMWPE acetabular insert previously cleared for Consensus in the following 510(k) s: K021466, K070061, and K100933. The vitamin E poly used in the new Consensus CS2 insert is identical to the poly cleared for the StelKast EXp acetabular liner in K094035 and K122773 (with the exception of the radiation dosing level).

Based on the material, characterization data, geometry and mechanical testing, the new VitalitE CS2 Hip is substantially equivalent to legally marketed predicates.

#### Legally Marketed Devices to which Substantial Equivalence is claimed:

K100933 (Consensus Orthopedics, Inc.): Consensus CS2 Plus Acetabular Inserts (lateralized) K070061 (Hayes Medical, Inc.): Consensus Hip System 36mm Femoral Head & Acetabular Insert K021466 (Haves Medical, Inc.): Cross Linked Polyethylene Acetabular Insert K122773 (SteKast, Inc.): Cross-Over Acetabular Shell and Liner (lateralized) K094035 (StelKast, Inc.): EXp Acetabular Shell Liner K112802 (Pipeline Orthopedics, Inc.): Pipeline Total Hip System

#### Non-Clinical Performance Data:

Non-clinical testing and analysis were provided, including bench testing, material characterization, and biocompatibility testing. Bench testing of the new stem design included wear testing of the worst case acetabular insert, in addition to disassembly testing which included push-out, and torque-out tests.

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All of the observed results indicate that the VitalitE Acetabular Insert is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.

:

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 17, 2013

Consensus Orthopedics, Incorporated Matthew M. Hull. RAC Director, Ouality Systems & Regulatory Affairs 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

Re: K130652

Trade/Device Name: VitalitE Acetabular Insert for the CS2" Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, LPH, LZO, OQI, KWL, KWY, LWJ, JDI, OQH Dated: November 4, 2013 Received: November 5, 2013

Dear Mr. Hull:

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 -Matthew M. Hull, RAC

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 vour device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 1. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130652

Device Name: VitalitE Acetabular Insert for the CS2TM Acetabular Cup System

#### Indications for Use:

The Consensus CS2™ Acetabular Cup System is indicated for use with the CONSENSUS® Hip System, TaperSet Hip System, CS2 Hip System, or UNISYN™ Hip System for the following indications:

- A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn, TaperSet, and CS2 femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S · 2013.12.13 16:08:40 -05'00'

## Division of Orthopedic Devices