(163 days)
Not Found
No
The document describes a ceramic femoral head for hip replacement and its intended use and testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a component of a hip replacement system, indicated for various conditions of the hip joint to restore function, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a hip replacement component (femoral head) intended for surgical implantation to replace a hip joint. Its purpose is therapeutic (replacement of damaged anatomical structures), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly indicates it is a physical medical device (a ceramic femoral head) and describes non-clinical testing related to its mechanical properties. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a component of a hip replacement system, designed to replace a hip joint. This is a surgical implant, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the material and design of a ceramic femoral head, a physical component of a hip implant.
- Performance Studies: The performance studies focus on mechanical testing (compression, fatigue, pull-off, torsion) of the implant's structural integrity, not on the accuracy or reliability of a diagnostic test.
- Anatomical Site: The anatomical site is the hip joint, where the implant is surgically placed.
- Intended User: The intended user is a surgeon, who performs the surgical implantation.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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 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
Product codes
LZO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head/neck, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name: | Signature Ceramic Femoral Head |
| Common Name: | Hip Prosthesis |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | 26 July 2019 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer
semi-constrained cemented or non-porous uncemented
prosthesis (LZO) |
| Predicate Devices: | Primary Predicate
Signature Orthopaedics Signature Ceramic Femoral Head (K121297) |
| | Additional Predicate
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
5
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.