(266 days)
Not Found
No
The summary describes a mechanical fixation device made of nitinol and PEEK, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a fixation system for bone and soft tissue repair, providing mechanical support during the healing process rather than treating a disease or condition itself.
No
The PUMA System is intended for fracture repair and fixation of bone-to-bone or soft tissue-to-bone, acting as a structural support rather than a tool for diagnosis. Its purpose is to physically stabilize and aid healing, not to identify or characterize medical conditions.
No
The device description explicitly states that the PUMA System comprises physical components: a suture made of nitinol and two anchors made of PEEK. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for fracture repair and fixation of bone and soft tissue. This is a surgical/implantable device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components (suture and anchors) and their function in providing stability during healing. This aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
The PUMA System is a surgical implant used to provide mechanical support and fixation during the healing process of fractures and soft tissue injuries.
N/A
Intended Use / Indications for Use
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
- . Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
- Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
- Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.
Product codes
HTN
Device Description
The PUMA System comprises three components: one suture (PUMA Body) made of a nickel titanium alloy (nitinol), and two anchors (PUMA Anchors) made of polyether-ether-ketone (PEEK). The PUMA Body is inserted through bones or soft tissues that need to be stabilized. Once placed, the device secures the bone and/or tissue by means of the PUMA Anchors affixed to each side of the Body. The elastic/superelastic shape characteristic of the nitinol confers some flexibility while maintaining the stability of the PUMA System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metaphyseal, and periarticular small bone fragments, Syndesmosis disruptions in connection with Weber B and C ankle fractures, dorsal distal radioulnar ligament (DRUL) disruptions, Tarsometatarsal (TMT) injury, Lisfranc Injury, 1st and 2nd metatarsal
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 tests were performed to demonstrate safety based on current industry standards:
- Biocompatibility risk assessment per ISO 10993-1
- . Bacterial Endotoxin Testing per ANSI/AAMI ST72
- . Extractable/Leachable Chemical Analysis and Toxicological Risk Assessment
- Pull-out Force
- Cyclic Fatigue Testing
- Tensile Testing (pre- and post-cyclic fatigue testing)
- . Corrosion Testing (on the final trimmed device)
The results of these tests indicate that the PUMA System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2018
Panther Orthopedics, Inc. % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104
Re: K171703
Trade/Device Name: PUMA System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: January 26, 2018 Received: January 26, 2018
Dear Dr. Komiyama:
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
1
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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171703
Device Name PUMA System
Indications for Use (Describe)
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The PUMA System when used for fixation of bone-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
- · Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
- Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
- · Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
- · Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal angle.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
510(k) Summary K171703
DATE PREPARED
February 27, 2018
MANUFACTURER AND 510(k) OWNER
Panther Orthopedics, Inc. 5279 Apennines Circle, San Jose, CA 95138, USA Telephone: Official Contact: Kathryn A. Stecco, M.D., CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
PUMA System
COMMON NAME
Washer, Bolt Nut
DEVICE CLASSIFICATION
Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030, Product Code HTN, Class II)
PREMARKET REVIEW
Orthopedic Review Panel
INDICATIONS FOR USE
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
4
The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
- . Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
- Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
- Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.
DEVICE DESCRIPTION
The PUMA System comprises three components: one suture (PUMA Body) made of a nickel titanium alloy (nitinol), and two anchors (PUMA Anchors) made of polyether-ether-ketone (PEEK). The PUMA Body is inserted through bones or soft tissues that need to be stabilized. Once placed, the device secures the bone and/or tissue by means of the PUMA Anchors affixed to each side of the Body. The elastic/superelastic shape characteristic of the nitinol confers some flexibility while maintaining the stability of the PUMA System.
PREDICATE DEVICE IDENTIFICATION
The PUMA System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K090107 | Mini TightRope / Arthrex, Inc. | ✓ |
| K043248 | TightRope Syndesmosis Device / Arthrex, Inc. | |
| K142727 | CrossCLIP Implant System / OrthoDiscovery Group, LLC |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the PUMA System. The following tests were performed to demonstrate safety based on current industry standards:
- Biocompatibility risk assessment per ISO 10993-1
- . Bacterial Endotoxin Testing per ANSI/AAMI ST72
- . Extractable/Leachable Chemical Analysis and Toxicological Risk Assessment
- Pull-out Force
- Cyclic Fatigue Testing
- Tensile Testing (pre- and post-cyclic fatigue testing)
- . Corrosion Testing (on the final trimmed device)
The results of these tests indicate that the PUMA System is substantially equivalent to the predicate devices.
5
EQUIVALENCE TO PREDICATE DEVICES
The subject device has the same intended use, identical indications for use, and similar design as the devices cleared in K090107 and K043248. The subject device uses similar materials as the device cleared in K142727. Overall, the subject and predicate devices have similar technological characteristics (a body that generates compression that is secured to tissue or bone) to the devices cleared in K090107, K043248, and K142727. Any differences in technological characteristics do not raise different questions of safety and effectiveness, and performance data demonstrate substantial equivalence to the predicates.
CONCLUSION
Based on the testing performed, including biocompatibility, pull-out force, and tensile strength, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed PUMA System are assessed to be substantially equivalent to the predicate devices. The subject device is considered as safe and effective for its intended use as the predicate device.