(50 days)
Not Found
No
The 510(k) summary describes a hip and knee replacement system with a focus on material changes and minor design updates. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a hip and knee replacement system, which clearly addresses medical conditions and aims to restore function, meeting the definition of a therapeutic device.
No
The device description indicates that the product, consisting of hip and knee replacement components, is intended to replace joints and improve function, not to diagnose medical conditions.
No
The device description clearly states it is a modification to physical components (polyethylene liners and patella) of hip and knee replacement systems, which are hardware implants.
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 devices as components of hip and knee replacement systems, designed to replace damaged joints. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical components of the implants (liners, patella) and their function within the joint replacement system. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Use in a laboratory setting for diagnostic purposes.
The device is a medical device intended for surgical implantation to treat musculoskeletal conditions.
N/A
Intended Use / Indications for Use
The Logical Liner and World Liner 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 intended 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.
Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions: Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other treatments or devices have failed; Fractures that are unmanageable using other techniques. Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LPH, JWH, MBH
Device Description
The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments.
The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head.
The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.
The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, Knee joint
Indicated Patient Age Range
Skeletally mature
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)
Engineering evaluations were conducted to verify that the performance of the Logical Acetabular, World Hip and World Knee systems with Vit-E HXLPE variants are equal to and/or better than the predicate devices and therefore adequate for anticipated clinical use. The following V&V activities were conducted:
- V&V of substantial equivalence of material properties of the Vit-E HXLPE relative to the predicates:
- Density as per ASTM F648 and D792;
- Mechanical Properties as per ASTM F648, F2759, D695 and F2183;
- Melting Point, Crystallinity and Enthalpy of Fusion as per ASTMF26351;
- Swell Ratio and Crosslink Density as per ASTM F2214;
- Fatigue Crack Propagation and Coefficient as per ASTM E647;
- Oxidation Challenge as per ASTM F2003 and analysis as per ASTM F2012 (both 2 and 6-weeks accelerated aging);
- ESR Testing for residual free radical content and Transvinylene Index (TVI) as per ASTM F2381; and
- Resistant to wear for 5 million cycles as per ISO 14243 Part 1 and 2.
- Wear and impingement assessment
- Verification of substantial equivalence of the mechanical integrity of the Vit-E HXLPE components including any locking mechanisms relative to the standard UHMWPE components.
- Risk Analysis and Design Control Review found no new or changed risks
The results of the V&V testing, associated engineering review, risk analysis and design control activities demonstrated substantial equivalence of the subject device systems to their primary predicates cited herein.
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.
K153131, K121297, K201278, K180750, K181530, K192071
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2024
Signature Orthopaedics Pty Ltd Declan Brazil Managing Director 7 Sirius Road Lane Cove West, NSW 2066 Australia
Re: K241690
Trade/Device Name: Logical Liner; World Liner; World Knee Patella 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, JWH, MBH Dated: July 29, 2024 Received: July 29, 2024
Dear Dr. 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun-S
Limin Sun, Ph.D. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
510(k) Number (if known) K241690
Device Name Logical Cup; World Acetabular Cup;
Indications for Use:
Logical Liner and World Liner
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 intended 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
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Indications for Use
510(k) Number (if known) 241690
Device Name World Knee System
Indications for Use (Describe)
Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions: · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
· Inflammatory degenerative joint disease including rheumatoid arthritis.
- · Functional deformity such as varus, valgus or flexion deformities.
- · Revision procedures where other treatments or devices have failed.
- · Fractures that are unmanageable using other techniques.
Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Logical Liner, World Liner, World Knee Patella |
| Common Name: | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer,
Non-Porous, Calcium Phosphate (MEH)
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous
Uncemented (LPH)
Prosthesis, Knee, Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/Polymer (JWH)
Prosthesis, Knee, patello/femorotibial, semi-constrained,
uncemented, porous, coated, polymer/metal/polymer (MBH) |
| Contact: | Dr. Declan Brazil
Managing Director, Signature Orthopaedics Pty Ltd |
| 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: | July 26th, 2024 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/
polymer semi-constrained cemented or nonporous uncemented
prosthesis
Class II per 21 CFR 888.3560: Knee joint
patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis |
| Predicate Devices: | Substantial equivalence to the following devices is claimed,
• Signature Orthopaedics Logical Acetabular
(K153131) - Primary Predicate
• Signature Orthopaedics Logical Acetabular
(K121297)
• Signature Orthopaedics World Liner (K201278)
• Signature Orthopaedics World Knee System
(K180750 and K181530)
• InSitu Total Hip System (NextStep Arthropedix, K192071) |
5
Image /page/5/Picture/0 description: The image contains the logo for SignatureOrtho. The logo consists of a green circle with a white figure inside, followed by the text "SignatureOrtho" in gray. The "TM" symbol is located to the upper right of the word "Ortho".
Device Description:
The primary purpose of this Special 510(k) Device Modification to devices cleared as part of the Logical Cup, World Hip, and World Knee System, is to notify the FDA of the the change in materials used to manufacture the polyethylene components (Logical Liner, World Liners and World Knee Patella) to Vitamin-E Stabilized, 100 kGy crosslinked UHMWPE (Vit-E HXLPE) that is the subject of Masterfile MAF 2795. This 510(k) also notifies the FDA of minor design updates to the implants and reusable instruments.
The Logical Acetabular System consists of an Acetabular Shell and a highly cross-linked polyethylene Acetabular Liner that is available in neutral, hooded and lateralized variants. The liner is designed to sit within an acetabular shell and articulate with a femoral head.
The World Liners are compatible with World Acetabular Cups and are available in neutral, and hooded variants. The liners are designed to sit within an acetabular shell and articulate with a femoral head.
The World Knee Patella is available in symmetrical and asymmetrical variants, with pegs. It is part of the World Knee System, which is a modular knee system consisting of a femoral component, meniscal inert, a patella and a tibial component.
Indications for Use:
Logical Liner and World Liner
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 intended 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
World Knee System
Patients should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:
· Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- · Inflammatory degenerative joint disease including rheumatoid arthritis.
- · Functional deformity such as varus, valgus or flexion deformities.
6
Image /page/6/Picture/1 description: The image contains the logo for SignatureOrtho. The logo consists of a green circle with a white figure inside, followed by the text "SignatureOrtho" in gray. The letters are in a sans-serif font, and there is a small superscript "TM" next to the word "Ortho".
- · Revision procedures where other treatments or devices have failed.
- · Fractures that are unmanageable using other techniques.
Signature Orthopaedics' World Knee replacement components may be intended for cemented or cementless use.
Intended Use:
The intended use for the Logical Acetabular, World Liner and World Knee System are identical to their previously cleared predicate devices (K121297, K153131. K201278, K180750 and K181530).
Components of the Signature Orthopaedics hip replacement range (Logical Acetabular and World Hip) are intended to replace a hip joint where bone stock is sufficient to support the implant.
The World Knee Total Knee System's intended use is for total knee replacement procedures in skeletally mature patients with structural joint damage.
Comparison of Technological Characteristics:
The Logical Acetabular, World Hip and World Knee System described in this Special 510(k) Device Modification are essentially the same device as the respective primary predicate devices cleared in K121297, K153131, K201278, K180750 and K181530. The technological characteristics that remain the same for the subject device systems are as follows:
- . Indications for Use, Intended Use and Surgical Techniques for the Vit-E HXLPE Variants and the previously cleared UHMWPE components are identical except changes to the polyethylene materials.
- The manufacturing process of the Vit-E HXLPE Variants have the same ● manufacturing processes as the previously cleared systems. This includes cleaning and passivation, packaging, transportation, and sterilization.
- The Vit-E HXLPE Variants have the same geometry and fundamental design as ● the previously cleared predicate devices. All interconnections between components are the same.
- All implants are provided sterile with SAL of 106 as seen in the predicate systems. ●
- The Vit-E HXLPE Variants have the same body contacts as previously cleared . systems, and as such have the same contact stresses.
The primary differences between the subject and primary predicate devices are as follows:
- . Vitamin-E Stabilised and 100kGy crosslinked UHMWPE (Vit-E HXLPE) material was added as an option for manufacturing of the Logical Liners, World Liners, and World Knee Patella; and
- Updates to implant and reusable instrument components to improve usability ● and/or functionality, and facilitate surgery.
Performance Testing:
Engineering evaluations were conducted to verify that the performance of the Logical Acetabular, World Hip and World Knee systems with Vit-E HXLPE variants are equal to and/or better than the predicate devices and therefore adequate for anticipated clinical use. The following V&V activities were conducted:
- V&V of substantial equivalence of material properties of the Vit-E HXLPE relative to the predicates:
- o Density as per ASTM F648 and D792;
7
Image /page/7/Picture/0 description: The image shows the logo for SignatureOrtho. The logo features a green circle with a white figure inside, followed by the text "SignatureOrtho" in gray. The "TM" symbol is located to the right of the word "Ortho".
- Mechanical Properties as per ASTM F648, F2759, D695 and F2183; O
- Melting Point, Crystallinity and Enthalpy of Fusion as per ASTMF26351; O
- Swell Ratio and Crosslink Density as per ASTM F2214; O
- Fatigue Crack Propagation and Coefficient as per ASTM E647; O
- Oxidation Challenge as per ASTM F2003 and analysis as per ASTM O F2012 (both 2 and 6-weeks accelerated aging);
- ESR Testing for residual free radical content and Transvinylene Index O (TVI) as per ASTM F2381; and
- Resistant to wear for 5 million cycles as per ISO 14243 Part 1 and 2. O
- Wear and impingement assessment ●
- Verification of substantial equivalence of the mechanical integrity of the Vit-E ● HXLPE components including any locking mechanisms relative to the standard UHMWPE components.
- Risk Analysis and Design Control Review found no new or changed risks
Substantial Equivalence:
The results of the V&V testing, associated engineering review, risk analysis and design control activities demonstrated substantial equivalence of the subject device systems to their primary predicates cited herein.