Signature Ceramic Femoral Head

K190704 · Signature Orthopaedics Pty, Ltd. · LZO · Aug 28, 2019 · Orthopedic

Device Facts

• Record ID: K190704
• Device Name: Signature Ceramic Femoral Head
• Applicant: Signature Orthopaedics Pty, Ltd.
• Product Code: LZO · Orthopedic
• Decision Date: Aug 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis - Correction of functional deformity including congenital hip dysplasia - Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are 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

Modular ceramic femoral head; composed of alumina matrix composite with zirconia reinforcement. Designed for articulation with UHMWPE acetabular liners in total hip arthroplasty. Features 12/14 taper for compatibility with Signature Orthopaedics femoral stems. Used by orthopedic surgeons in clinical settings to restore hip joint function. Provides stable bearing surface for patients with degenerative or traumatic hip conditions. Benefits include improved wear resistance and biocompatibility compared to metal-on-polyethylene alternatives.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via axial compression, fatigue, post-fatigue ultimate compression, static pull-off, and static torsion testing on worst-case sizes.

Technological Characteristics

Material: Alumina matrix composite with zirconia reinforcement (ISO 6474-2). Form factor: Modular femoral head with 12/14 taper. Connectivity: None. Sterilization: Not specified. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), inflammatory joint disease (rheumatoid arthritis), functional deformity (congenital hip dysplasia), traumatic injury (traumatic arthritis, femoral head/neck fracture), or failed previous hip surgery. Specific components indicated for hemi-hip arthroplasty in patients with femoral head/neck fractures or pathologies.

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

• Signature Orthopaedics Signature Ceramic Femoral Head (K121297)
• ICONACY Orthopedic Implants ICONACY I-Hip Ceramic Head (K151307)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 28, 2019

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

Re: K190704

Trade/Device Name: Signature Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: July 26, 2019 Received: July 29, 2019

Dear Declan 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vesa Vuniqi, Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190704

Device Name Signature Ceramic Femoral Head

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

- · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis
- · Correction of functional deformity including congenital hip dysplasia
- · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture

· Failed previous hip surgery including internal fixation, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are 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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY

| Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade<br>Name: | Signature Ceramic Femoral Head |
| Common Name: | Hip Prosthesis |
| Contact: | Dr. Declan Brazil<br>Managing Director of Signature Orthopaedics |
| 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: | 26 July 2019 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer<br>semi-constrained cemented or non-porous uncemented<br>prosthesis (LZO) |
| Predicate Devices: | Primary Predicate<br>Signature Orthopaedics Signature Ceramic Femoral Head (K121297) |
| | Additional Predicate<br>ICONACY Orthopedic Implants ICONACY I-Hip Ceramic Head (K151307) |

### Device Description:

The modular Signature Ceramic Femoral Head is composed of alumina matrix composite with zirconia reinforcement, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on Signature Orthopaedics' range of femoral heads. The device is compatible for use across any of Signature Orthopaedics' total hip component range, and articulates with UHMWPE acetabular liner.

### Indications for Use:

Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a

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surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- . Inflammatory joint disease including rheumatoid arthritis
- Correction of functional deformity including congenital hip dysplasia .
- Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI and Pegasus femoral stems, SignaSure Cementless Cup and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems, and SignaSure Cemented Cup are intended for cemented fixation only. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are 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

## Non-Clinical Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Ceramic Femoral Head is equal or better than the predicate device and therefore adequate for anticipated in-vivo use. The following nonclinical tests were carried out on the worst case sizes of Signature Ceramic Femoral Heads:

- . Axial Compression Test
- . Fatigue Test
- . Post Fatigue Ultimate Compression Strength Test
- . Static Pull-Off Test
- . Static Torsion Test

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### Substantial Equivalence:

The Signature Ceramic Femoral Head has the same intended use, indications for use, design and materials as the rest of the relevant Signature Orthopaedics' ceramic femoral head range (K121297) and ICONACY's I-Hip Ceramic Femoral Head (K151307).

#### Comparison of technological characteristics

The subject device has the same material, manufacturing process, body contact, design and sterilization method as the predicate devices. The subject and Signature Ceramic Head (CeramTec) predicate device differ in the subcontract manufacturer.