Evolve UniPolar Head

K143184 · Signature Orthopaedics Pty, Ltd. · KWL · Mar 17, 2015 · Orthopedic

Device Facts

• Record ID: K143184
• Device Name: Evolve UniPolar Head
• Applicant: Signature Orthopaedics Pty, Ltd.
• Product Code: KWL · Orthopedic
• Decision Date: Mar 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - Acute femoral head or neck fracture - Fracture dislocation of the hip - Avascular necrosis of the femoral head - Non-union of femoral neck fractures - Certain high subcapital and femoral neck fractures in the elderly - Degenerative arthritis involving only the femoral head

Device Story

Metallic femoral head prosthesis; connects to femoral stem via taper sleeve; highly polished outer surface articulates against natural acetabulum. Used in hemi-hip arthroplasty procedures; performed by orthopedic surgeons in clinical/hospital settings. Device replaces damaged femoral head/neck; restores hip joint function; benefits patients with fractures or degenerative pathologies. Design utilizes existing taper connection geometry for compatibility with manufacturer's femoral stem range.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing including range of motion analysis, component connection strength, fretting corrosion testing, and femoral stem fatigue testing.

Technological Characteristics

Metallic ball (cobalt-chromium alloy per ISO 5832-12) with tapered bore; includes 12/14 taper sleeve. Highly polished articular surface. Standalone orthopedic implant.

Indications for Use

Indicated for patients requiring hemi-hip arthroplasty due to femoral head/neck or proximal femur fractures, fracture dislocations, avascular necrosis, non-union of femoral neck fractures, or degenerative arthritis of the femoral head, where the natural acetabulum remains intact.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Signature Orthopaedics Origin Total Hip System CoCr Femoral Head (K121297)
• Signature Orthopaedics BiPolar Head (K133370)
• Smith & Nephew Tandem UniPolar Head (K896580)
• Global Manufacturing Technology MSA Hip System (K102172)

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

March 17, 2015

Signature Orthopaedics Pty Ltd. Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia

Re: K143184 Trade/Device Name: Evolve™ UniPolar Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: February 9, 2015 Received: February 11, 2015

Dear Dr. Brazil:

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 - Dr. Declan Brazil

(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/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,

# Lori A. Wiggins -S

for

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 STATEMENT 1

510(k) Number (if Known): K143184

Device Name: Evolve™ UniPolar Head

Indications For Use:

Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

- Acute femoral head or neck fracture ●
- . Fracture dislocation of the hip
- Avascular necrosis of the femoral head ●
- Non-union of femoral neck fractures
- Certain high subcapital and femoral neck fractures in the elderly ●
- . Degenerative arthritis involving only the femoral head

Prescription Use: Yes Over-The-Counter Use: No AND/OR (Part 29 CFR 801 Subpart D) (Part 29 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)

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Signature Orthopaedics Pty Ltd

#### 510(K) SUMMARY 2

| Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Evolve™ UniPolar Head |
| Common Name: | Hip Prosthesis |
| Contact: | Dr. Declan Brazil<br>Managing Director |
| Prepared By: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | October 21st, 2014 |
| Classification: | Class II per 21 CFR 888.3360: Prosthesis, Hip, Hemi-,<br>Femoral, Metal (KWL) |
| Predicate Devices: | Substantial equivalence to the following devices is claimed:<br>● Signature Orthopaedics Origin Total Hip System CoCr<br>Femoral Head (K121297)<br>● Signature Orthopaedics BiPolar Head (K133370)<br>● Smith & Nephew Tandem UniPolar Head (K896580)<br>● Global Manufacturing Technology MSA Hip System<br>(K102172) |

## Device Description:

The Evolve™ UniPolar Head is a metallic (per ISO 5832-12) ball with a tapered bore. The head connects to a femoral stem from Signature Orthopaedics' range via taper sleeve. The taper sleeve is manufactured from cobalt-chromium alloy per ISO 5832-12, and includes a 12/14 taper. The head's outer surface is highly polished to articulate against the patient's natural acetabulum as part of a hip hemi-arthroplasty.

# Indications for Use:

Signature Orthopaedics' Evolve UniPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head is indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

- . Acute femoral head or neck fracture

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Signature Orthopaedics Pty Ltd

- . Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- Non-union of femoral neck fractures ●
- Certain high subcapital and femoral neck fractures in the elderly ●
- Degenerative arthritis involving only the femoral head ●

# Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Evolve™ UniPolar Head is adequate for anticipated in-vivo use. Non-clinical testing included:

- . Range of motion analysis
- Component connection strength and fretting corrosion testing ●
- . Femoral stem fatigue testing

## Substantial Equivalence:

The Evolve UniPolar Head's design is similar to the Signature Orthopaedics CoCr Femoral Head (K121297), including articular surface and taper connection geometry, to allow use with Signature Orthopaedics existing femoral stem range. The Evolve UniPolar Head's design and intended use are similar to the Signature Orthopaedics BiPolar Head (K133370) and Smith & Nephew Tandem UniPolar Head (K896580). Non-clinical testing results support the substantial equivalence claim. The Evolve UniPolar Head is expected to perform adequately during clinical use.