NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL

K111572 · Serf · LZO · Aug 29, 2011 · Orthopedic

Device Facts

• Record ID: K111572
• Device Name: NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
• Applicant: Serf
• Product Code: LZO · Orthopedic
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes: - Osteoarthritis - Femoral neck fracture - Dislocation risk - Osteonecrosis of the femoral head - Revision procedures where other treatments or devices have failed and if bone reconstruction so permits SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

Device Story

NOVAE® Dual Mobility Acetabular Cup is a total hip prosthesis component; consists of metallic shell and mobile UHMWPE liner. Metallic shell fixed in acetabulum via cement (NOVAE STICK) or press-fit (SUNFIT TH, NOVAE E TH, COPTOS TH). Liner remains mobile within shell and is retained on prosthetic femoral head (Ø22.2 or 28 mm). Used by orthopedic surgeons in OR for primary or revision hip arthroplasty. Provides dual mobility to reduce dislocation risk. Fixation reinforced by pegs/cortical screws in specific models. Clinical benefit: restoration of hip function and stability.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing including dimensional analysis, push-out force, head insertion/pull-out/lever-out force, bending cycles, flange fracture testing, coating characterization, range of motion, and wear analysis.

Technological Characteristics

Metallic shell: Stainless steel (ISO 5832-1:2007). Cementless coating: CP titanium and hydroxyapatite plasma spray. Liner: UHMWPE (ISO 5834-2:2006). Fixation: Cemented or press-fit with optional stainless steel pegs/cortical screws. Dual mobility design with mobile liner. Sterilization method not specified.

Indications for Use

Indicated for total hip replacement in patients with osteoarthritis, femoral neck fracture, dislocation risk, osteonecrosis of the femoral head, or requiring revision procedures where bone reconstruction permits. Available as cemented (NOVAE STICK) or press-fit (SUNFIT TH, NOVAE E TH, COPTOS TH) versions.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• POLARCUP® dual mobility system (K070278)
• Restoration™ ADM system (K072020)
• Tri-Polar system and RingLoc® + modular acetabular shell (K991990)

Submission Summary (Full Text)

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AUG 2 9 2011

## 510(k) Summary

Date: August the 23th 2011

| Company name and address: | SERF |
|---------------------------|-------------------------------------|
| | 85 avenue des Bruyères |
| | 69153 Décines Cedex |
| | FRANCE |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact person: | Caroline GELLY |
| | Regulatory Affairs Engineer |
| Date prepared: | August the 23rd, 2011 |
| Trade name: | NOVAE® Dual Mobility Acetabular Cup |

Classification name: Hip joint metal/ceramic/polymer semi-constrained cemented or

Total hip prosthesis – Acetabular component

nonporous uncemented prosthesis (21 CFR 888.3353, Product Code LZO/MEH)

## Device description

Common name:

The NOVAE® Dual Mobility Acetabular Cup is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.

### Cemented metallic shell:

- NOVAE STICK: the cemented metallic shell is made of stainless steel according to ISO 5832-1:2007. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.

### Cementless metallic shell:

The cementless metallic shell is made of stainless steel according to ISO 5832-1:2007 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.

Three cementless metal-backs are available:

- SUNFIT TH: the SUNFIT TH version is available without the pegs and screw, and is a press fit onlv.

- NOVAE E TH: the NOVAE E TH has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).

- COPTOS TH: the COPTOS TH has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).

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## Liner:

The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2:2006. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.

## Pegs and cortical screws:

When applicable, primary fixation can be reinforced by impacted pegs and self tapping cortical screws made of stainless steel according to ISO 5832-1:2007.

## Substantial equivalence claimed to predicate devices

NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to the POLARCUP® dual mobility system (K070278, PLUS Orthopedics) in terms of intended use, design, range of sizes, materials used, mechanical safety and performances, the Restoration™ ADM system (K072020, Stryker) in terms of intended use, design and metal-back coating and the Tri-Polar system and RingLoc® + modular acetabular shell (K991990, BIOMET) in terms of intended use, design and range of sizes.

| Device | NOVAE® Dual<br>Mobility<br>Acetabular Cup | POLARCUP® dual<br>mobility system | Restoration™<br>ADM System | Tri-Polar system<br>and RingLoc®<br>+ modular<br>acetabular shell |
|----------------------------------|-------------------------------------------|-------------------------------------------------------|----------------------------------|-------------------------------------------------------------------|
| 510(k) number | / | K070278 | K072020 | K991990 |
| Intended use | | | | |
| Total hip<br>replacement | Yes | Yes | Yes | Yes |
| Cementless/<br>cemented | Yes/Yes | Yes/No | Yes/No | Yes/No |
| Primary/<br>Revision | Yes/Yes | Yes/Yes | Yes/No | Yes/Yes |
| Design | | | | |
| Dual mobility | Yes | Yes | Yes | Yes |
| Metal-back and<br>a mobile liner | Yes | Yes | Yes | No<br>(bipolar head +<br>acetabular cup) |
| Screws | Cortical | Cortical | No screws | Screws |
| Pegs | Grooved | Grooved | No pegs | No pegs |
| Liner is retained<br>on the head | Yes | Yes | Yes | Yes |
| Materials | | | | |
| Metal-back | Stainless steel (ISO<br>5832-1:2007) | High nitrogen<br>stainless steel (ISO<br>5832-9:1992) | Wrought Cobalt<br>Chromium alloy | Titanium alloy |
| Metal-back<br>coating | CP titanium and HA | CP titanium | CP titanium and HA | Titanium alloy |
| Liner | UHMWPE | UHMWPE | UHMWPE | Polyethylene |
| Pegs and Screws | Stainless steel | Stainless | Not applicable | Unknown |

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## Intended use

NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

- . Osteoarthritis
- Femoral neck fracture .
- Dislocation risk .
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

## Non-clinical Test Summary

The following tests were conducted:

- . Dimensional analysis (acceptance criteria was met)
- . Uncemented metal-back push-out force (acceptance criteria was met)
- Head insertion force and Head Pull-Out testing (acceptance criteria was met) .
- . Head lever out force (acceptance criteria was met)
- Number of bending cycles to flange fracture (acceptance criteria was met) .
- Characterization of CP titanium and HA plasma spray (acceptance criteria was met) .
- Range Of Motion Analysis (acceptance criteria was met) .
- Wear Analysis (acceptance criteria was met)

## Clinical Test Summary

No clinical studies were performed

Conclusions Nonclinical and Clinical

The NOVAE® dual mobility acetabular cup is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and performance.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird or abstract design. The logo is presented in black and white.

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

SERF % Mr. J.D. Webb Orthomedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

AUG 2 9 2011

Re: K111572

Trade/Device Name: NOVAE® Dual Mobility Acetabular Cup Regulation Number: 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: May 5, 2011 Received: June 6, 2011

Dear Mr. Webb:

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, 7 ug 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 1/0 hast 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

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Page 2 - Mr. J.D. Webb

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

yours,

Melkerson

Mark N. Melkerso Director Division of Surgical, Orthopedic

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): / K\\1572 (pg 1/1)

Device Name: NOVAE® Dual Mobility Acetabular Cup

Indications For Use:

NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

- . Osteoarthritis
- . Femoral neck fracture
- . Dislocation risk
- . Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone . reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for m melleer

(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Orthopedic,
Division of Surgical, Orthopedic, Division of Surger
and Restorative Devices

510(k) Number