(67 days)
No
The summary describes a mechanical implant system and associated instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests focused on mechanical properties.
Yes
This device is a surgical implant designed to treat osteoarthritis and other conditions of the patello-femoral joint, which directly addresses a disease state to improve a patient's health.
No
Explanation: This device is a Patellofemoral System, an orthopedic implant designed for surgical replacement in patients with osteoarthritis or previous failed surgeries. It is an implantable device used for treatment, not for diagnosing a condition.
No
The device description explicitly details physical implants made of titanium and UHMWPE, as well as ancillary instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Overture Orthopaedics Patellofemoral System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in cemented arthroplasty in patients with specific knee conditions. This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device is described as comprising trochlear and patellar implants, which are physical components designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is designed to be implanted within the body.
N/A
Intended Use / Indications for Use
The Overture Orthopaedics Patellofemoral 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 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 Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces.
The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm.
The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
distal patello-femoral joint (knee)
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)
The following bench testing was performed on the Overture Orthopaedics Patellofemoral System:
- Patellofemoral Contact Area and Contact Stress Testing
- Patellofemoral Constraint Testing
- Patellofemoral Cadaveric Validation Lab
- Range of Motion Analysis
- Fatigue Strength Adoption Rationale
- Wear Testing Adoption Rationale
- Additive Manufacturing Rationale
- Characterization of UHMWPE Adoption Rationale
- Characterization of Porous Coating Adoption Rationale
- Testing the Modified Metallic Surfaces Adoption Rationale
In summary, rationales and mechanical testing of the Overture Orthopaedics Patellofemoral System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 7, 2023
Overture Resurfacing Inc. % Benjamin Arnold CEO Cor Medical Ventures, Inc. 2010 Jimmy Durante Blvd Suite 200 Del Mar, California 92014
Re: K231253
Trade/Device Name: Overture Orthopaedics Patellofemoral 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: April 20, 2023 Received: May 1, 2023
Dear Benjamin Arnold:
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.
1
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 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 medical devices and radiation-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.
Lixin Liu -S
Lixin Liu, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231253
Device Name Overture Orthopaedics Patellofemoral System
Indications for Use (Describe)
The Overture Orthopaedics Patellofemoral 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 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) |
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3
510(K) SUMMARY
SUBMITTER:
| Company Name:
Address: | Overture Resurfacing Inc.
1617 3rd Avenue
#287284
New York, NY 10128 |
|---------------------------|---------------------------------------------------------------------------------------------------|
| Telephone: | 607.351.6131 |
| CONTACT PERSON: | Benjamin Arnold |
| DATE PREPARED: | 7/7/2023 |
| TRADE NAME: | Overture Orthopaedics Patellofemoral System |
| COMMON NAME: | Patellofemoral System |
| CLASSIFICATION NAME: | Knee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis (21 CFR 888.3540) |
| REGULATORY CLASS: | II |
| PRODUCT CODE: | KRR |
| Predicate Device: | Arthrosurface, Inc. HemiCAPTM Patello-Femoral Resurfacing Prosthesis
(K060127) |
| Reference Device: | Overture Resurfacing Inc. Uni Knee Resurfacing System (K221292) |
DEVICE DESCRIPTION:
The Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces.
The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm.
The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
MATERIALS:
The Overture Orthopaedics Patellofemoral System trochlear implants are additively manufactured from Ti-6Al-4V ELI per ASTM F3001 and have a TiN coated articulating surface. The Overture Orthopaedics
4
Patellofemoral System patellar implants are compression-molded from highly cross-linked UHMWPE and feature a titanium pin.
INDICATIONS FOR USE:
The Overture Orthopaedics Patellofemoral 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 DISCUSSION:
The Overture Orthopaedics Patellofemoral System is substantially equivalent to the predicate device in all facets including function, design, performance, material, and intended use.
The Overture Orthopaedics Patellofemoral System devices are made from similar materials and have equivalent design philosophy, sizing, configurations, fixation methods, sterilization and packaging, and surgical approach to the predicate devices. Any differences between the Overture Orthopaedics Patellofemoral System devices and the predicates are considered minor and do not raise questions concerning safety or effectiveness.
PERFORMANCE TESTING:
The following bench testing was performed on the Overture Orthopaedics Patellofemoral System:
- Patellofemoral Contact Area and Contact Stress Testing
- Patellofemoral Constraint Testing
- Patellofemoral Cadaveric Validation Lab
- Range of Motion Analysis
- Fatigue Strength Adoption Rationale
- Wear Testing Adoption Rationale
- Additive Manufacturing Rationale
- Characterization of UHMWPE Adoption Rationale ●
- Characterization of Porous Coating Adoption Rationale
- Testing the Modified Metallic Surfaces Adoption Rationale
In summary, rationales and mechanical testing of the Overture Orthopaedics Patellofemoral System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
CONCLUSIONS:
The Overture Orthopaedics Patellofemoral System is substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.