(217 days)
Not Found
No
The document describes a mechanical hip replacement system and its components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing.
Yes
The device is described as a hip replacement component, which is a medical device intended to treat conditions of the hip joint. Its stated purpose to "replace a hip joint" for various pathologies falls under the definition of a therapeutic device.
No
The device is a hip replacement component, which is a therapeutic device used to replace a joint, not to diagnose a condition.
No
The device description clearly details physical components made of metal and polyethylene, intended for surgical implantation. There is no mention of software as a component of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a hip replacement system designed to replace a hip joint in patients with various conditions affecting the hip. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the materials and construction of the physical components of the hip replacement (acetabular shell, liners, etc.). This aligns with a medical device intended for implantation, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents or calibrators
The device is a surgical implant used to treat a condition, not a tool for diagnosing or monitoring a condition through in vitro analysis.
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 or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems 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 hemihip 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
Product codes (comma separated list FDA assigned to the subject device)
MEH, LPH, KWZ
Device Description
The Logical C-Series Acetabular Shell is a metal backed cementless acetabular cup that is compatible with a highly cross-linked polyethylene liner from the Origin Total Hip System predicate device (K121297), as well as the Logical Constrained Liner and Logical 20° Hooded Liner. The shell's substrate is manufactured from Ti6A14V alloy per ASTM F136. The outer surface of the shell is sequentially coated with commercially pure titanium (per ASTM F1580) and Hydroxylapatite (per ISO 13779-2). The shell is available in no-hole. 3-hole or multi-hole configurations to allow use of bone screws for supplemental fixation.
The Logical Constrained Liner and the Logical 20° Hooded Liner are line range extensions to the Logical Liner per K121297. The Logical Constrained Liner differs from the original range in that it provides greater than 180 degree head coverage to constrain the head within liner. The Logical 20° Hooded Liner differs from the original range in that it incorporates a 20° hood as opposed to the original 10° hood. The Logical Constrained Liner and Logical 20° Hooded Liner are manufactured from highly crosslinked polyethylene (XLPE) identical to the Logical Liner per K121297. The Logical Constrained Liner further incorporates a titanium alloy collar to support the liner's rim. Furthermore, the Logical Constrained Liner is assembled with the Logical Shell and Logical Constrained Liner Collar via titanium alloy snapring. The Logical Constrained and 20° Hooded Liners articulate with a femoral head of appropriate diameter.
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, acetabulum
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 Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use. Non-clinical testing included:
- Range of motion analysis
- Shell stiffness testing
- Modular component connection strength testing
- Cup-Liner Push Out testing
- Head-Liner Assembly / Disassembly Testing
- Liner-Shell Assembly Testing
- Various coating characterization, abrasion and adhesion strength testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031495, K001448, K043058, K052079, K071117, K001534, K000306, K121297, K951301, K972596, K021803, K033442
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
June 3, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Signature Orthopaedics Pty Ltd. Dr. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 AUSTRALIA
Re: K153131
Trade/Device Name: Logical C-series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner 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: MEH, LPH, KWZ Dated: April 20, 2016 Received: April 25, 2016
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
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 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.
Mark N. Melkerson -S
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): - - K153131
Device Name: Logical C-Series Shell, Constrained Liner and 20° Hooded 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 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, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems 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 hemihip 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
| Prescription Use: | Yes |
|---|---|
| (Part 29 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use: | No |
|---|---|
| (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
510(K) SUMMARY 2
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Logical C-Series Shell, Constrained Liner and 20° Hooded
Liner |
| Common Name: | Total 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: | October 26th, 2015 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous uncemented prosthesis
(MEH)
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented prosthesis (LPH)
Class II per 21 CFR 888.3310: Hip joint metal/polymer
constrained cemented or uncemented prosthesis (KWZ) |
| Predicate Devices: | Substantial equivalence to the following devices is claimed:
• DePuy Pinnacle Duofix HA Acetabular Cup Prosthesis
(K031495)
• Howmedica Osteonics Trident Acetabular Shells: PS-
HA (K001448)
• DePuy Pinnacle Constrained Acetabular Liner
(K043058, K052079, K071117)
• Pinnacle Acetabular System (K001534, K000306)
• Signature Origin Total Hip System (K121297)
• DePuy Duraloc Constrained Liner (K951301, K972596)
• Smith & Nephew Reflection Constrained Liner
(K021803, K033442) |
4
Device Description:
The Logical C-Series Acetabular Shell is a metal backed cementless acetabular cup that is compatible with a highly cross-linked polyethylene liner from the Origin Total Hip System predicate device (K121297), as well as the Logical Constrained Liner and Logical 20° Hooded Liner. The shell's substrate is manufactured from Ti6A14V alloy per ASTM F136. The outer surface of the shell is sequentially coated with commercially pure titanium (per ASTM F1580) and Hydroxylapatite (per ISO 13779-2). The shell is available in no-hole. 3-hole or multi-hole configurations to allow use of bone screws for supplemental fixation.
The Logical Constrained Liner and the Logical 20° Hooded Liner are line range extensions to the Logical Liner per K121297. The Logical Constrained Liner differs from the original range in that it provides greater than 180 degree head coverage to constrain the head within liner. The Logical 20° Hooded Liner differs from the original range in that it incorporates a 20° hood as opposed to the original 10° hood. The Logical Constrained Liner and Logical 20° Hooded Liner are manufactured from highly crosslinked polyethylene (XLPE) identical to the Logical Liner per K121297. The Logical Constrained Liner further incorporates a titanium alloy collar to support the liner's rim. Furthermore, the Logical Constrained Liner is assembled with the Logical Shell and Logical Constrained Liner Collar via titanium alloy snapring. The Logical Constrained and 20° Hooded Liners articulate with a femoral head of appropriate diameter.
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 or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems 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 hemihip 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
5
- 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 Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use. Non-clinical testing included:
- Range of motion analysis
- . Shell stiffness testing
- . Modular component connection strength testing
- . Cup-Liner Push Out testing
- Head-Liner Assembly / Disassembly Testing
- . Liner-Shell Assembly Testing
- . Various coating characterization, abrasion and adhesion strength testing
Substantial Equivalence:
The Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices have similar intended use, indications for use, materials and design to the predicate devices. Non-clinical testing results support the substantial equivalence claim. The Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are expected to perform adequately during clinical use.