(132 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and articulation of a metallic hip implant component. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making.
No.
The device is a component of a hip hemi-arthroplasty system, intended to replace the femoral head and neck but not to treat a disease or condition itself.
No
The device is an implantable medical device used in hemi-hip arthroplasty, not for diagnosing medical conditions.
No
The device description clearly states it is a metallic ball with a tapered bore, connecting to a femoral stem, indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Evolve UniPolar Head is a metallic implant intended for surgical implantation in the hip to replace the femoral head. It articulates against the patient's natural acetabulum. This is a surgical device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Evolve UniPolar Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
KWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head/neck and/or proximal femur (hip)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121297, K133370, K896580, K102172
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
Signature Orthopaedics Pty Ltd
510(K) SUMMARY 2
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Evolve™ UniPolar Head |
| Common Name: | Hip Prosthesis |
| Contact: | Dr. Declan Brazil
Managing Director |
| 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: | October 21st, 2014 |
| Classification: | Class II per 21 CFR 888.3360: Prosthesis, Hip, Hemi-,
Femoral, Metal (KWL) |
| Predicate Devices: | Substantial equivalence to the following devices is claimed:
● 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) |
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
4
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.