(30 days)
No
The summary describes a mechanical implant and surgical instrumentation, with no mention of AI/ML capabilities or data processing.
Yes
The device is an arthroplasty system intended to treat osteoarthritis, patellar dislocation, or patellar fracture, and failed previous surgery, indicating it is used for therapeutic purposes by replacing or repairing a diseased or damaged joint.
No
Explanation: The device described is an arthroplasty system intended for surgical implantation in patients with osteoarthritis or patellar issues. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components (femoral component, patella components, instrumentation set, reamers, implant trials) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating conditions in the patello-femoral joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a system of implants (femoral and patella components) and associated instrumentation for surgical implantation. This aligns with a medical device used in surgery, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies listed are related to the mechanical and biological safety of the implant (comparative analysis, contact area, subluxation testing, endotoxin testing), which are typical for surgical implants, not IVDs.
In summary, the device is a surgical implant intended for the treatment of patello-femoral joint conditions, which falls under the category of a medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
Product codes
KRR
Device Description
The Patello-Femoral Wave《hung Arthroplasty System is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing System.
The line extension consists of a larger femoral component for increased coverage of the trochlear groove. The additional sizes will address larger defects of the superior aspect of the trochlea and provide greater coverage superiorly. The system also includes larger mating UHMWPE patella components as described within.
The larger PF Kahuna trochlear Patello-Femoral Wave"«ከ«ባ articular component is designed to mate with the currently marketed Arthrosurface Patello-Femoral fixation component.
The majority of the implantation technique steps are the same. The PF Kahuna trochlear component is implanted using the same Instrumentation Set as with the HemiCAP™ Patello-Femoral Resurfacing System, with the addition of a reaming operation to create the superior ream. The reamers, associated implant trials etc. are contained within an adjunct Patello-Femoral WaveKahuna Instrumentation Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal patello-femoral joint
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
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis ●
- Contact Area Analysis ●
- o Lateral Subluxation Testing
- A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The results have demonstrated the safety and effectiveness of the Patello-Femoral Wave'&humo Arthroplasty System along with substantial equivalence to the predicate device (K071413).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2018
Arthrosurface, Inc. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K181280
Trade/Device Name: Patello-Femoral Wave (Kahuna) Arthroplasty System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRR Dated: May 10, 2018 Received: May 15, 2018
Dear Dawn Wilson:
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 (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 (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K181280
Device Name
Patello-Femoral Wave (Kahuna) Arthroplasty System
Indications for Use (Describe)
Indications for Use:
Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
| 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.
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3
510(k) Summary
Special 510(k): Device Modification Patello-Femoral Wave《hun® Arthroplasty System
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory
Tel: 508.520.3003
Fax: 508.528.4604
dwilson@arthrosurface.com |
| Establishment Registration
Number: | 3004154314 |
| Date of Preparation: | May 10, 2018 |
| Proprietary Name: | Patello-Femoral WaveKahuna Arthroplasty System |
| Common Name: | Knee Joint Patello-Femoral Arthroplasty System |
| Device: | Prosthesis, Knee, Patello/Femoral, Semi-Constrained,
Cemented, Metal/Polymer |
| Regulation Description: | Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis |
| Regulation Number: | 888.3540 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KRR |
4
Device Description
The Patello-Femoral Wave《hung Arthroplasty System is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing System.
The line extension consists of a larger femoral component for increased coverage of the trochlear groove. The additional sizes will address larger defects of the superior aspect of the trochlea and provide greater coverage superiorly. The system also includes larger mating UHMWPE patella components as described within.
The larger PF Kahuna trochlear Patello-Femoral Wave"«ከ«ባ articular component is designed to mate with the currently marketed Arthrosurface Patello-Femoral fixation component.
The majority of the implantation technique steps are the same. The PF Kahuna trochlear component is implanted using the same Instrumentation Set as with the HemiCAP™ Patello-Femoral Resurfacing System, with the addition of a reaming operation to create the superior ream. The reamers, associated implant trials etc. are contained within an adjunct Patello-Femoral WaveKahuna Instrumentation Kit.
Indications for Use
The Patello-Femoral Wave《hun® Arthroplasty System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Patello-Femoral Wave«««««««« » System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:
HemiCAP Patello-Femoral Resurfacing Prosthesis K071413
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
- Has the same Indications for Use .
- Uses the same operating principle
- 0 ls manufactured using the same implant grade orthopedic materials
- Utilizes similar instrumentation for proper placement
- 0 Is packaged and sterilized using the same materials and processes
5
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis ●
- Contact Area Analysis ●
- o Lateral Subluxation Testing
- A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
Conclusion
The results have demonstrated the safety and effectiveness of the Patello-Femoral Wave'&humo Arthroplasty System along with substantial equivalence to the predicate device (K071413).