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.

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.

AI/ML Overview

This document is a 510(k) Summary for the PUMA System, a medical device intended for fracture repair and fixation. It describes the device, its indications for use, and a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states, "No FDA performance standards have been established for the PUMA System." Therefore, there are no specific, quantitative acceptance criteria listed that the device's performance needs to meet against a defined numerical threshold. Instead, the "acceptance criteria" are implicitly to demonstrate safety and effectiveness based on current industry standards and equivalence to predicate devices through the following non-clinical tests:

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (per ISO 10993-1)	Pass: "Biocompatibility risk assessment per ISO 10993-1" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices."
Sterility/Endotoxin Absence (per ANSI/AAMI ST72)	Pass: "Bacterial Endotoxin Testing per ANSI/AAMI ST72" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices."
Material Safety - Chemical Analysis (Extractables/Leachables)	Pass: "Extractable/Leachable Chemical Analysis and Toxicological Risk Assessment" was performed. Conclusion: "does not raise new issues of safety or effectiveness compared to the predicate devices."
Mechanical Stability - Pull-out Force	Pass: "Pull-out Force" testing was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided.
Mechanical Durability - Cyclic Fatigue	Pass: "Cyclic Fatigue Testing" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided.
Material Strength - Tensile Testing (pre- and post-cyclic)	Pass: "Tensile Testing (pre- and post-cyclic fatigue testing)" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided.
Material Integrity - Corrosion	Pass: "Corrosion Testing (on the final trimmed device)" was performed. Conclusion: "performance data demonstrate substantial equivalence to the predicates," and "does not raise new issues of safety or effectiveness compared to the predicate devices." The specific numerical outcome is not provided.
Substantial Equivalence (Overall)	Achieved: "The subject device is considered as safe and effective for its intended use as the predicate device." "The results of these tests indicate that the PUMA System is substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing (bench testing), not a clinical trial with a "test set" of patients. Therefore, information regarding "sample size used for the test set" in the context of human subjects or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned (Biocompatibility, Pull-out Force, Cyclic Fatigue, etc.) would have involved specific numbers of device samples or materials, but these sample sizes are not detailed in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the summary describes non-clinical (bench) testing, not a clinical study involving human patients where expert readers would establish ground truth for a diagnostic or interventional outcome.

4. Adjudication Method:

This information is not applicable as the summary describes non-clinical (bench) testing, not a clinical study involving human patients where adjudication of expert readings would be required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention any MRMC comparative effectiveness study or any study involving human readers with or without AI assistance. The testing performed was non-clinical.

6. Standalone (Algorithm Only) Performance Study:

No. The PUMA System is described as comprising physical components (suture, anchors). It is a mechanical device, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not relevant or mentioned.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established by engineering and material science standards and measurements. For example:

Biocompatibility: Conformance to ISO 10993-1.
Pull-out Force: Measured force applied to the device until failure, compared against expected mechanical properties or predicate device performance.
Tensile Strength: Measured force to achieve specified elongation or fracture, compared against material specifications or predicate device performance.
Corrosion: Visual inspection or other analytical methods to detect material degradation.

The document implicitly uses these established engineering and material science "ground truths" to determine if the device performed as expected and equivalently to its predicates.

8. Sample Size for the Training Set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering principles, not statistical learning from data in a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

Summary

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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

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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

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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 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)

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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

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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

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.

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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.

Regulation Number and Section

§ 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.